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Happy Holidays from Masimo!
This has been an exciting and successful year for Masimo and we wish to share our success with charitable organizations by making a donation on your behalf. As we continue with our mission to solve unsolvable problems that will improve patient care, we would like to thank those of you who encourage and improve us with your collaboration and high standards.
For many years, we have conducted business in accordance with our Guiding Principles, and in 2004 we added the fifth principle: Do What is Best For Patient Care. This is the most important objective of healthcare practitioners, and today it consciously guides every decision we make. In 2004, we demonstrated our commitment to this principle by developing the Blue Sensor, optimized for a very small but important population of cyanotic infants.
As a show of gratitude to those of you who have supported the cause for better care, and to fulfill our heart-felt responsibility to give something back to our world community, Masimo would like to donate $5 to a charity of your choice. We have carefully selected the following organizations committed to better care and a better world, and we will make a contribution on behalf of each person who is an official member of Livewire as of today, and who responds to this Livewire with their choice from the list below:
Please send us e-mail at: email@example.com to specify your selection. Only requests by e-mail will be processed. We also would appreciate comments and suggestions from you on our mission and guiding principles, which are listed below, or any other suggestions you may have.
Masimo's Mission is to improve patient outcome and reduce cost of care by making noninvasive monitoring effective and reliable and taking noninvasive monitoring to new sites and applications.
We look to our Guiding Principles in pursuit of this Mission:
Medtronic LIFEPAK 12 Defibrillator/Monitor Adds Masimo Signal Extraction Technology for Pulse Oximetry
IRVINE, Calif. and REDMOND, Wash., December 6, 2004 — Masimo Corporation, the innovator and leader of Signal Extraction Pulse Oximetry, and Medtronic, the world's leading medical technology company, today announced that Masimo SET® pulse oximetry technology is now available in LIFEPAK® 12 defibrillator/monitors.
Pulse oximetry continuously tracks pulse rate and oxygen saturation in the blood to determine trends and warn of decreasing saturation levels. The LIFEPAK 12 defibrillator/monitor is used in both mobile emergency medical services and hospital settings. Medtronic's LIFEPAK 20 defibrillator/monitor, which is used mostly in hospital and clinic settings, has included Masimo SET Pulse Oximetry technology since 2002.
"We design and build our products with an eye to the needs of both the users and the patients," said Robert White, president of Medtronic's Emergency Response Systems business unit. "Masimo SET technology has been a successful component of the LIFEPAK 20 and the inclusion of this technology in the LIFEPAK 12 will be very beneficial to the overall management of emergency patient care."
Joe E. Kiani, CEO of Masimo, stated, "We are proud to be working with Medtronic to help emergency care providers revive patients. We have always respected Medtronic's commitment to patient care, and we are pleased to be represented as the pulse oximetry technology of choice in Medtronic's products."
About Masimo Masimo, founded in 1989, is the innovator and leader of read-through motion and low perfusion pulse oximetry. Masimo develops, licenses, and markets advanced medical signal processing technologies and products for the noninvasive monitoring. Masimo Signal Extraction Technology, or Masimo SET, represents the standard of care for pulse oximeters. Over 100 clinical studies support the conclusion that Masimo SET is the most effective pulse oximeter in the world. Masimo is headquartered in Irvine, California. Additional information about Masimo and its products can be found at http://www.masimo.com.
About Medtronic Medtronic's Emergency Response Systems business unit, located in Redmond, Wash., pioneered defibrillation technology nearly 50 years ago. With 475,000 LIFEPAK defibrillators distributed worldwide, it is the world's leading provider of external defibrillators for the treatment of sudden cardiac arrest. For more information on LIFEPAK defibrillator/monitors, visit http://www.medtronic-ers.com/ or call 1-800-442-1142. Medtronic, Inc. (NYSE: MDT), headquartered in Minneapolis, is the world's leading medical technology company, providing lifelong solutions for people with chronic disease. For more information about Medtronic, visit http://www.medtronic.com/ or call 1-800-328-2518.
Masimo Announces Support for the Medical Device Competition Act of 2004, Designed to Enhance Clinicians' Choice in the Care They Provide Their Patients
November 10, 2004 - IRVINE, California - Masimo, the innovator of Signal Extraction Pulse Oximetry, today announced its support of the "Medical Device Competition Act of 2004," which seeks to promote greater competition within the medical technology industry and enhance the freedom of clinicians to choose the care they believe is best for their patients. In addition, this bill aims to increase competition, the improvement of products made available for patient care, and make available competitive pricing for hospitals. The bill was introduced last month by United States Senators Herb Kohl (D - Wisconsin) and Mike DeWine (R - Ohio), Ranking Member and Chairman of the Senate Subcommittee on Antitrust, Competition Policy, and Consumer Rights.
Almost every product purchased by most hospitals is acquired through contracts with group purchasing organizations (GPOs). Hospitals join GPOs with the expectation of paying lower prices for the products they purchase. GPOs are funded by fees paid by manufacturers and distributors, based upon the sales volume of products purchased through each GPO contract. For the last three years, the Subcommittee has been investigating the GPO industry. As a result of that investigation and other actions that have spotlighted questionable industry practices, HIGPA, the GPO's trade association, adopted a baseline code of conduct and six of the nation's leading GPOs enacted voluntary codes of conduct to address anticompetitive and unethical business practices.
In the past ten years, hospital purchasing power has been largely in the hands of GPOs and not in the hands of clinicians who are most aware of what technologies will best help their patients. The cost savings promised by GPOs as a trade-off for limiting product choices is not always realized, however. Two studies done by the Government Accountability Office, upon request of the Subcommittee, showed that 1) purchasing with GPO contracts did not ensure that hospitals saved money, and 2) GPOs, which control over 95% of hospital purchases, have adopted codes of conduct that are not uniform and some cases include exceptions and qualified language that effectively nullify their potential to affect the changes necessary to promote technological innovation and free and open competition. You can read more about GAO report 2002, and GAO report 2003
In order to assist the GPO industry to make meaningful changes in their business practices, Senators DeWine and Kohl introduced the Medical Device Competition Act of 2004, on September 28, 2004, after the third Subcommittee Hearing on GPO business practices. In their press release announcing the bill, Senators Kohl and DeWine stated, "Our goal is to ensure that physicians and patients have access to the highest quality medical products at the lowest prices, and to prevent improper barriers to competition among hospital suppliers. We also want to ensure that GPOs fulfill their important purpose - to cut prices for thousands of hospitals across the country and thereby restrain health care costs. We believe our bill strikes the right balance and accomplishes these goals. It will ensure that the considerable reforms we have already achieved in the hospital purchasing industry will not be lost should our scrutiny of this industry be lessened."
"Our bill will ensure that GPOs act in the best interests of patients and hospitals. Giving the Department of Health and Human Services oversight of this industry will help prevent improper practices that can endanger patients' access to the best and safest products," added Senator Kohl.
Senator DeWine, the Chairman of the Subcommittee, stated, "We have come a long way with the GPO industry. Through many discussions and hard work on the voluntary codes, manufacturers, hospitals, doctors and other healthcare workers, and most importantly patients, are all better off. This bill is another step in the process and I look forward to working with all the interested parties to assure that we continue to progress towards better, safer and less expensive healthcare."
Joe E. Kiani, founder and CEO of Masimo, stated, "GPOs were granted special exemptions from anti-kickback laws by Congress in an effort to help hospitals negotiate lower prices. The Medical Device Act of 2004 is necessary to help ensure that GPOs use this advantage to benefit hospitals and the patients they care for." Mr. Kiani continued, "When we introduced a breakthrough technology to the market and found that most hospitals could not purchase it due to GPO contracts even though our product was based on superior technology and offered a lower price, we knew something was wrong. Fortunately, the New York Times took up the investigation and did much to expose a practice that ultimately hurt patients because it impeded clinicians' access to lifesaving technology. However, the bipartisan efforts of Senator Kohl and Senator DeWine brought hope for those who truly want to help patients. Last month, after three hearings and over three years of investigation, Senators Kohl and DeWine introduced this legislation. This bill, if passed, should result in increased competition, which in turn will result in better products available to hospitals at competitive prices. We thank the Subcommittee and especially Senators Kohl and DeWine for their courageous efforts to improve our nation's healthcare."
To learn more about the Senate Hearings and the Medical Device Act of 2004 Bill, view: www.masimo.com/About-Masimo/news--media/archived-news/senate-hearing-update/.
Research Presented at the 2004 American Society of Anesthesiologists Conference Finds New Uses for Masimo SET Perfusion Index and Validates the Clinical Value of Masimo SET TC-I Ear Sensor
Studies also continue to question the efficacy of forehead sensors
LAS VEGAS, Nevada - October 27, 2004 - Research presented at the 2004 American Society of Anesthesiologists (ASA) conference in Las Vegas, NV, October 24-26, included two studies on new clinical applications of Masimo SET perfusion index and in another study hailed the clinical value of the Masimo SET TC-I Ear sensor. Also at the conference, three separate studies continued to show poor performance with forehead pulse oximetry sensors and cautioned clinicians attempting to use them clinically.
The Value of Perfusion Index The Masimo SET Perfusion Index (PI) is a relative assessment of the perfusion at the monitoring site. Various researchers have found that the Masimo SET PI may be diagnostically useful in assessing patient well-being, in therapeutic efforts, and in indicating pain stimuli during anesthesia.
Mitchell Goldstein, M.D., FAAP, and a team of researchers from Citrus Valley Medical Center in West Covina, CA, tested the Masimo SET Perfusion Index's diagnostic applicability on neonates with respect to the Neonatal Therapeutic Intervention Scoring System (NTISS). The researchers found that there is a statistically significant difference in PI between patients in the NTISS-identified "sick" and "well" groups. Dr. Goldstein stated, "It appears that PI can provide a useful independent measure of sickness and well-being, and it may be an important adjunct to the ASA system of assessment of perioperative morbidities."1
Dr. Helmut Hager from Washington University, St. Louis, Missouri, used the Masimo SET PI functionality on anesthetized volunteers during the application of painful stimuli. Dr. Hager found that the PI declined significantly from its baseline level during pain stimuli. He also noted a weak correlation between endtidal Sevoflurane concentration and perfusion index. Based on this evidence, Dr. Hager concluded, "The perfusion index is able to independently indicate a noxious stimulus in anesthetized volunteers in different concentrations of Sevoflurane. Thus it may be of clinical value to assess pain."2
TC-I Ear Sensor Hailed Daniel Redford, M.D., and other researchers from the Department of Anesthesiology, University of Arizona at Tucson, compared the Nellcor Max-Fast forehead sensor to the Masimo SET LNOP TC-I earlobe sensor.3 Their data showed that the TC-I sensor performed significantly better than the Max-Fast sensor. Dr. Redford stated, "Masimo SET technology and the advent of the TipClip sensor has totally changed the way I practice anesthesiology, especially in pediatrics. It is the most accurate and reliable sensor I've used. I carry one in my pocket. On congenital heart patients, I usually use three pulse oximeters with sensors on preductal, postductal, and a central site with a TipClip sensor."
Dr. Redford continued, "For those accustomed to Nellcor, they need to compare it side-by-side with Masimo to get a feel for the difference. It is not appropriate to conclude which technology is better when you haven't tried both. Masimo has even offered a $250,000 guarantee that they will win any side-by-side clinical evaluation."
Limitation of Forehead Sensors In a separate study, Dr. Helmut Hager used the Nellcor Max-Fast sensor on surgical patients.4 Dr. Hager said, "We discovered the limitations of the forehead sensor during routine lung surgery, not when we were trying to see if we could throw it off. We simply had a patient turned on his right side because we were operating on his left lung, so we had the forehead sensor on the right side of the forehead, which is standard practice. We also had a headband on, which has been said to help the sensor read. But the sensor just would not work - it kept losing readings. The only time we could get a reading is after we had expelled pooled venous blood by applying much pressure with our fingers; once we relieved the pressure, we could get a reading until the venous blood had time to pool again. And what we found is that this error is completely reproducible. Every time the sensor was placed on the dependent side during surgery, the sensor would drop out. There is more work to be done on these sensors before they will be really useful in surgery."
In a second study, Dr. Redford showed significant performance and reliability differences between the Masimo TF-I forehead sensor and the Nellcor Max-Fast forehead sensor in the Operating Room.5 The Masimo forehead TransFlectance sensor, with a Performance Index of 99.4%, performed significantly better than the Nellcor Max-Fast forehead sensor, which generated a performance index of 79.8%. Dr. Redford said, "Because the Nellcor Max-Fast sensor had significantly longer periods of time where the SpO2 reading was falsely low, it is unacceptable for use in the pediatric surgical patient. In contrast, the superior performance of the Masimo Radical TF-I forehead sensor produced superior results, evidenced by a small bias and precision."
Aman Mahajan, M.D., and a team of researchers from the Department of Anesthesiology at UCLA School of Medicine, reported poor performance with the Max-Fast sensor in a population of adult surgical patients. Dr. Mahajan concluded, "This study demonstrates poor performance of the forehead reflectance pulse oximeter. In our patients, the Max-Fast sensor attached to the N595 oximeter demonstrated an unacceptable bias and precision was in error by more than 5% for more than 20% of the total operative time in eleven (55%) of the cases studied. This forehead sensor is not accurate or reliable enough for clinical use in pediatric surgical patients."6
About Masimo Masimo, founded in 1989, is the innovator and leader of read-through motion and low perfusion pulse oximetry. Masimo develops, licenses, and markets advanced medical signal processing technologies and products for the noninvasive monitoring of vital signs. Masimo Signal Extraction Technology, or Masimo SET, represents the standard of care for pulse oximeters. Over 100 clinical studies support the conclusion that Masimo SET is the most effective pulse oximeter in the world. Masimo is headquartered in Irvine, California. Additional information about Masimo and its products can be found at http://www.masimo.com.
Masimo is currently offering a $250,000 guarantee to hospitals seeking an upgrade to next generation pulse oximetry. If Masimo does not outperform Nellcor in an objective clinical trial, Masimo will pay that hospital $250,000 towards the purchase of Nellcor oximetry. Contact Masimo for more details.
1 Goldstein MR, Sindel BD, Furman GI, Ochikubo CG, Martin GI. Perfusion index (PI) correlates with the neonatal therapeutic intervention scoring system (NTISS) as an indication of clinical well-being. Poster A-1430, 2004 ASA, Las Vegas, NV. 2 Hager H, Church S, Mandadi G, Pulley D, Kurz A. The Perfusion Index Measured by a Pulse Oximeter Indicates Pain Stimuli in Anesthetized Volunteers. Poster A-514, 2004 ASA, Las Vegas, NV. 3 Redford D, Lichtenthal P, Barker S. An Intraoperative Comparison of Ear Transmission and Forehead Reflectance Oximetry in Pediatric Surgical Patients. Poster A-579, 2004 ASA, Las Vegas, NV. 4 Hager H, Mandadi G, Reddy D, Pulley D, Kurz A. Clinical Experiences with a New Forehead Reflectance Pulse Oximetry Sensor in ASA II Patients During Surgery. Poster A-564, 2004 ASA, Las Vegas, NV. 5 Redford D, Lichtenthal P, Barker S. Evaluation of 2 Forehead Reflectance Oximeters in Pediatric Intraoperative Surgical Patients, Poster A-593, 2004 ASA, Las Vegas, NV. 6 Mahajan A, Lee E, Moldovan A. Intraoperative Use of Forehead Reflectance Oximetry in Pediatric Patients. Poster A-590, 2004 ASA, Las Vegas, NV.
Masimo SET Reaches 200,000th Shipment
IRVINE, California - October 14, 2004 - Masimo, the innovator and leader of read-through motion and low perfusion pulse oximetry, today announced that it has shipped its 200,000th Masimo Signal Extraction Technology pulse oximeter.
Since the initial commercial launch of Masimo SET (Signal Extraction Technology), read-through motion and low perfusion oximetry has become the standard of care in pulse oximetry. Prominent hospitals and health care centers worldwide have converted to Masimo SET, including Brigham and Women's, Johns Hopkins, UCLA, Hospital for Sick Children in Toronto, National Children's Hospital in Tokyo, Nippon Medical School in Tokyo, Assistance Publique de Paris, Leeds Health Authority in the UK, and Auckland City Hospital in New Zealand.
Before Masimo SET, pulse oximetry worked only when patient conditions were just right - motionless patients with strong pulses, and good perfusion. Today, Masimo SET pulse oximetry has been demonstrated in over 100 clinical studies to be a dramatic improvement in arterial blood oxygen and pulse rate monitoring and has been shown to contribute to improved patient outcomes. It has also become a key component in international protocols studying the prevention of Retinopathy of Prematurity (ROP), the infant eye disease that causes blindness in 2000 babies a year. As an added benefit to these performance improvements, Masimo SET has been shown to reduce overall expenditures.
Masimo SET has also ushered in a host of potential new applications for pulse oximetry, such as being diagnostically useful in predicting illness severity in neonates, detecting hypoplastic left heart syndrome, tracking and guiding resuscitative efforts, detecting changes in perfusion brought on by anesthetic agents and pain, and even being used to close the loop on ventilation and drug delivery. New applications for this robust technology are continually being discovered.
Joe E. Kiani, founder and CEO of Masimo, said, "Masimo's mission since inception has been to 'improve patient care and reduce cost of care by taking noninvasive monitoring to new sites and applications.' This mission drove the creation of Signal Extraction Technology and it still drives every step we take in terms of product development, customer service, community service and business strategy. We are happy that despite numerous obstacles and challenges, over 200,000 Masimo SET pulse oximeters are now improving patient care around the world. We could have not accomplished this without the support of leading clinicians and patient monitoring companies around the globe as well as the oversight of members of the US Senate in US Group Purchasing Practices."
Masimo Will Introduce Two New Specialty Sensors at the NANN Conference: The Blue Cyanotic Sensor and the Hi-Fi Trauma Sensor
The Blue Sensor is Designed Specifically for Cyanotic Babies and the Hi-Fi Trauma Sensor is designed for situations when seconds are important - ideal for emergency, trauma, and newborn delivery & resuscitation
IRVINE, California - October 6, 2004 - Masimo, the innovator of Signal Extraction Pulse Oximetry, today announced that it will debut two breakthrough Low Noise Optical Probe Specialty sensors at the NANN conference on October 13 in Orlando, Florida. The new LNOP Specialty sensors were designed to give clinicians maximum accuracy and reliability in difficult-to-monitor pediatric and neonatal situations, particularly in applications involving emergency, trauma, and newborn delivery & resuscitation monitoring. The development of these highly specialized sensors is part of Masimo's mission to ensure all patients are monitored accurately for optimal patient care.
The Masimo LNOP Blue Sensor is designed for cyanotic babies and children with congenital heart defects. Cyanotic babies' oxygen saturation is usually around 60% to 80% vs. the normal 90% to 95%. Pulse oximeters in the past have had poor accuracy and precision in this patient population. The LNOP Blue sensor has been designed to improve the accuracy in monitoring cyanotic patients. The LNOP Blue sensor is easily identified by a blue connector.
The Masimo LNOP Hi-Fi Trauma sensor was designed specifically for trauma situations, including accurate tracking through newborn resuscitation. To improve clinicians' efficiency in extreme situations, the LNOP Hi-Fi sensors automatically reconfigure Masimo SET oximeters to fastest-response and highest sensitivity modes, so clinicians don't have to spend precious seconds reconfiguring the oximeter. In addition, a unique combination of adhesive and cloth with Velcro secures the sensor to the patient even when the site is wet. The LNOP Hi-Fi sensor is easily identified by a yellow connector.
Peter Cox, MD, Clinical Director, Pediatric Intensive Care Unit, Hospital for Sick Children in Toronto, Canada stated, "We have been testing this new Blue sensor for several months on many cyanotic babies with oxygen saturations in the 60% to 80% range. We have compared the readings from the Masimo sensor to values obtained from the gold standard, CO-Oximetry. This new sensor has remarkable precision and accurately tracks the arterial oxygen saturation to low levels. In the past, oximeters have been inaccurate in this range. We have recently had a case where the Blue sensor accurately tracked arterial saturation to the low 30% range. These cyanotic patients are very difficult to monitor and this new sensor helps us more accurately assess these patients' oxygenation status."
Mitchell Goldstein, MD, Dept. of Neonatology, Queen of the Valley Hospital in West Covina, California, stated, "Time is crucial when infants are struggling for life. The Hi-Fi sensor helps clinicians maximize the time we can spend caring for patients. During newborn resuscitation, frequently nothing works. With Masimo, we have been able to successfully track newborn resuscitation."
Joe E. Kiani, founder & CEO of Masimo, said, "We have been able to design these sensors for very specific and challenging patient conditions by working with caring clinicians. We felt it was a shared responsibility to develop these new sensors for the care of these patients. Attention to the most challenging conditions where pulse oximetry can make a real difference is what Masimo is all about."
Latest Research Tests Performance of Next Generation Pulse Oximeters During Motion, Low Perfusion and Rapid Changes in Oxygenation
IRVINE, CA - September 30, 2004. Masimo, the innovator of Signal Extraction Pulse Oximetry, today announced a new study testing "Next Generation" pulse oximeters during challenging monitoring situations. This paper was presented at the 2004 annual meeting of the Society for Technology in Anesthesiology and was published in the October 2004 supplement of Anesthesia and Analgesia. It describes the latest study done by Steven J. Barker, MD, PhD, Chairman of the Department of Anesthesia of the University of Arizona and invited ASA speaker on the topic of Oxygen Monitoring. Dr. Barker compared the read-though motion and low perfusion capability of five "Next Generation" pulse oximeters set in their shortest averaging times while rapidly changing the oxygenation of the adult volunteers. The following table illustrates the results1:
The study concluded that Masimo SET has the highest sensitivity, specificity and overall best performance. Sensitivity is the ability to detect true alarms and specificity is the ability to reject false alarms.
Dr. Barker stated, "It's important to test all manufacturers' claims in their shortest averaging times. Longer averaging allows a pulse oximeter to smooth out poor data during motion, effectively masking inferior performance. The data we obtained in short averaging shows that Masimo SET provided the most accurate and reliable readings during motion and hypoxia. This is particularly important in high-risk patients and infants, in whom saturation values can change very rapidly."
1 Barker SJ, Anesthesia and Analgesia. A laboratory comparison of the newest "motion-resistant" pulse oximeters during motion and hypoxemia. 2004;98(5S):S2.
Masimo Introduces LNOP TC-I Arterial Blood-Oxygen, Perfusion Index and Pulse Rate Sensor to Bring Improved Monitoring to the Bedside
U.S. News & World Report
September 27, 2004 - Irvine, Calif.-based Masimo, the innovator of Signal Extraction Pulse Oximetry today announced the introduction of the LNOP TC-I ear pulse oximetry sensor. The sensor, used to record a patient's blood-oxygen level, pulse rate and perfusion index, was developed with feedback from The Cleveland Clinic, ranked as one of the nation's best hospitals by U.S. News & World Report.
Pulse oximetry technology involves applying a sensor to the skin to record a patient's blood-oxygen levels. A monitor continuously displays the data, and visual and audible alarms alert caregivers to unusual blood-oxygen levels and abnormal heart rates. Previously, pulse oximetry has been highly effective in monitoring those patients who are motionless, asleep and who have satisfactory circulation. Masimo is the innovator of Signal Extraction Technology for reliable pulse oximetry monitoring, even during patient motion and low perfusion.
In addition, the conventional pulse oximeter has had drawbacks for those patients having cardiac surgery or other surgical procedures where access to a typical monitoring site, such as the finger or toe, is not readily accessible. Many sites available during these procedures have lower levels of blood flow and, therefore, are more susceptible to physiologic, mechanical, thermal and optical noise that can mask low-level pulse oximetry signals.
The TC-I, Tip-Clip, ear sensor was designed by Masimo with assistance from the biomedical, clinical and nursing staff at The Cleveland Clinic. The goal was to create an ear sensor that would not drop out or freeze data under low perfusion and motion conditions, and that could obtain faster readings on central oxygenation changes than digit sensors because of its proximity to the heart.
The resulting TC-I has a smaller and lighter design, with a unique clear, soft, silicone lens material for better grip, and a slightly concave photo-detector for optimum conformity to the contours of the ear.
"Ear pulse oximetry sensors provide our operating rooms with a stable and highly reliable reusable probe, something that we have been trying to obtain for several years," said John Petre, Ph.D., Head of Clinical Engineering & Information Services, for the Division of Anesthesiology and Critical Care at The Cleveland Clinic.
A recent clinical study performed by Daniel Redford, MD, of University of Arizona compared the bias and precision of the TC-I sensor placed on the earlobe to the bias and precision of the Masimo LNOP digit sensor. While the Masimo digit sensor predictably performed better than the Masimo TC-I ear sensor, the difference was not large and validated the usefulness of the TC-I sensor when digits are unavailable or inappropriate for specific monitoring needs.
"The Cleveland Clinic relies on pulse oximetry to enhance patient safety," said Fawzy G. Estafanous, MD, Chairman, Division of Anesthesiology and Critical Care Medicine. "We began using Masimo SET over two years ago to measure blood-oxygen levels to enhance the level of care we can provide to patients at risk of cardio-respiratory complications."
Joe E. Kiani, Chairman and CEO of Masimo, stated, "The TC-I ear sensor has been a great addition to our sensor offering. Clinicians and researchers have given us very positive feedback on the design and performance of this product. We thank the Cleveland Clinic team for their assistance." Mr. Kiani continued, "The adoption of Masimo SET by The Cleveland Clinic is also a great honor for us. The Cleveland Clinic is a leading standard-setting healthcare institution. Our close working relationship with The Cleveland Clinic has resulted in improvement in our products for all of our customers."
About Masimo Masimo, founded in 1989, is the innovator and leader of read-through motion and low perfusion pulse oximetry. Masimo develops, licenses, and markets advanced medical signal processing technologies and products for the noninvasive monitoring of vital signs. Masimo Signal Extraction Technology, or Masimo SET, represents the standard of care for pulse oximeters. Over 100 clinical studies support the conclusion that Masimo SET is the most effective pulse oximeter in the world. Masimo is headquartered in Irvine, Calif. Additional information about Masimo and its products can be found at http://www.masimo.com.
Researchers Announce Major New Findings on the Health Dangers of Transient Oxygen Desaturations of the Blood
An Exhaustive Review of Direct Evidence Concludes that Transient Oxygen Desaturations Contribute to Long Term Cognitive and Behavioral Disorders
IRVINE, California - September 17, 2004 - Researchers at Massachusetts General Hospital have concluded that mild oxygen desaturations of the blood, once thought to be of limited harmfulness, contribute to long-term impaired mental function, such as decreased cognitive ability, poor academic performance, and behavioral disorders, such as Attention Deficit/Hyperactive Disorder (ADHD) in children. Prolonged as well as transient oxygen desaturations can occur as a result of many diseases and disabilities and are especially common and critical in newborns and children. The paper, "The Effect of Chronic or Intermittent Hypoxia on Cognition in Childhood: A Review of the Literature," was published this month in the September 2004 issue of Pediatrics.
A team of international researchers, led by Dr. Joel L. Bass of Massachusetts General Hospital, performed a comprehensive review of literature related to oxygen desaturation in children, spanning the years 1966 - 2000. 788 studies over nearly forty years were reviewed for inclusion. The researchers established stringent criteria of association for desaturation and decreased quality of life and the reviewed papers were all judged according to these criteria. 55 of these studies were judged to have used the most powerful methods of statistical analysis and data collection. The literature strongly supports the thesis that oxygen desaturations, either chronic or intermittent, and childhood cognitive problems are highly correlative.
Of the direct evidence observed, 78.2% of the articles showed that these desaturations have an adverse effect in children, leading to short and long term cognitive impairment. In the group of studies examining the effects of brief desaturations brought on by sleep-disordered breathing, for example, one report showed a mean IQ drop of 12 points in children with snoring (a condition closely associated with oxygen desaturation).
Reviewed studies by Blunden et al, O'Brien et al, Rosenthal, and Stradling et al showed symptoms of decreased IQ, impaired attention and ADHD at saturations between 85% and 94%, levels that would be considered not serious by most pulse oximetry manufacturers and in some clinical institutions.
"Some of the adverse effects were noted in reports with oxygen saturations just below the range of normal for age," stated the authors. "This information should be taken into account when managing clinical conditions and designing devices that may expose infants or children to any level of chronic or intermittent hypoxia, with the goal of minimizing potential risk whenever possible. Such risks should also be balanced with the potential risks of oxygen therapy."
Mike Petterson, RRT, Senior Director of Clinical Research for Masimo Corporation, stated, "This study comes at a critical time when some in our industry have been advocating that brief desaturations are "trivial" and are not necessary to track. We believe there is no such a thing as a "trivial" desaturation. Clinicians need to be made aware of every desaturation so that they can best care for their patients. When we developed Masimo SET, our goal was not to eliminate alarms; it was to eliminate false alarms and catch all true alarms. That's what we were told by clinicians: "give us the highest fidelity and let us decide what to do for the patients." Hence, the introduction of Masimo SET in 1996 and, in 2000, Masimo SET with FastSat, which provides the highest fidelity while rejecting false alarms. Today, Masimo SET has been reported to be the only pulse oximetry technology that delivers over 95% sensitivity and specificity. We are committed to pulse oximetry that accurately reports the depth and duration of oxygen desaturation in all clinical situations, including during periods of patient movement and low perfusion."
About Masimo Masimo, founded in 1989, is the innovator and leader of read-through motion and low perfusion pulse oximetry. Masimo develops, licenses, and markets advanced medical signal processing technologies and products for the noninvasive monitoring. Masimo Signal Extraction Technology, or Masimo SET, represents the standard of care for pulse oximeters. Over 90 clinical studies support the conclusion that Masimo SET is the most effective pulse oximeter in the world. Masimo is headquartered in Irvine, California. Additional information about Masimo and its products can be found at http://www.masimo.com.
Researchers Report Results of First Effective Automated Oxygen Delivery System to Titrate Oxygenation of Preterm Infants
Masimo's Pioneering Read-Through Motion Technology Cited Key to Success
IRVINE, California - September 9, 2004 - Masimo, the innovator of Signal Extraction Pulse Oximetry, today announced the publication in the September American Journal of Respiratory and Critical Care Medicine of a new study investigating automatically controlled oxygen therapy in preterm infants.1 Urschitz et al. developed a closed loop inspired oxygen (FiO2) system to automatically control the inspired oxygen fraction delivered to preterm infants in order to replace the time-consuming and often inappropriate practice of routine manual control. The study took place in Germany and used a randomized, controlled cross-over trial involving 12 pre-term infants.
Managing the inspired oxygen levels of preterm infants has been considered an important step in preventing oxygen-associated diseases such as ROP (Retinopathy of Prematurity), which can cause severe eye disability including blindness, and chronic lung disease. Excessive oxygen delivery as well as large fluctuations in oxygen delivery are thought to be primary contributors to preterm infant morbidity. Previously, Dr. Michael Urschitz and Dr. Christian Poets from the department of neonatology at Tuebingen, Germany, and a multi-institutional team of researchers published a study titled "Use of Pulse Oximetry in Automated Oxygen Delivery to Infants."2 In this study, they showed that Masimo SET correctly detected 217 of 223 true hypoxemia episodes for a sensitivity of 97%. The researchers reported that four of the six hypoxemias were missed due to the sensor being off the patient's skin. But all 6 were associated with the Masimo Low Signal IQ message. Signal IQ™ was further investigated and found to have excellent specificity (75%) and sensitivity (100%). Signal IQ is Masimo's unique signal identification and quality indicator that helps clinicians identify readings of questionable validity due to extremely challenging conditions. The researchers concluded that, "With the sensitivity and specificity of Masimo SET pulse oximetry measurement as well as Signal IQ, oxygen delivery to premature and/or critically ill infants may be optimized and perhaps automated."
In the new study, a statistically significant difference was shown to exist between automated oxygen adjustments and routine manual control with respect to the frequency of oxygen adjustments and the ability to keep the infant within a targeted oxygenation range. The researchers found that automatic oxygen control successfully kept the infants within the target range 91% of the time, whereas routine manual control was successful only 81.7% of the time. Because keeping oxygen stable and within the target range is so important in eliminating oxygen-related diseases such as ROP, the difference in success rates between automated and manual control is highly significant.
Michael Urschitz, MD of the Department of Neonatology at Tuebingen, Germany, said, "It's generally accepted that precise delivery of inspired oxygen is crucial to helping infants survive and avoid retinopathy of prematurity and chronic lung disease. Automatic oxygen control may help to reach that goal. However, prior to the introduction of Masimo SET technology, pulse oximeters were too unreliable. High artifact rates, as high as 90%, were the reality. We have spent a lot of time on the development of an algorithm for automatic oxygen control that is robust to motion artifacts. This is important, because automatically adjusting the inspired oxygen as a result of motion artifacts (saturation values are falsely low) would lead to hyperoxic episodes. This could be harmful to preterm infants and should be strictly avoided. Masimo SET has reduced those artifacts and increased the detection of hypoxic and hyperoxic episodes by reading through motion and low perfusion situations. This advancement has made pulse oximetry a useful tool for automatic oxygen control. In fact, using Masimo SET Oximetry was the breakthrough in the development of our automatic oxygen control system."
Joe Kiani, CEO of Masimo, stated, "This is a ground breaking study. Never before had any researcher shown this kind of success with automation of oxygenation. The fact that Masimo SET was a key component to the automated oxygen management system implemented by this group of clinicians makes us all proud. We hope that more lifesaving applications result from the advent of Signal Extraction Oximetry"
Contact: Brad Langdale Masimo Corporation. firstname.lastname@example.org (949) 297-7009
1 Urschitz MS, Horn W, Seyfang A, Hallenberger A, Herberts T, Miksch S, Popow C, Mueller-Hansen I, Poets CF. Automatic Control of the Inspired Oxygen Fraction in Preterm Infants. A Randomized Cross-Over Trial. American Journal of Respiratory Critical Care Medicine. Sept 2004. 2 Urschitz MS, Von Einem V, Seyfang A, Poets CF. Use of Pulse Oximetry in Automated O2 Delivery to Ventilated Infants. Anesthesia and Analgesea 2002;94(S1):S37-40.
The Methodist Hospital Converts to Masimo SET Oximetry
HOUSTON, Texas - September 2, 2004 - Masimo, the innovator and leader of Signal Extraction Pulse Oximetry, today announced that The Methodist Hospital, based in Houston, Texas, has standardized hospital-wide on Masimo SET Oximetry. Methodist, a 4-hospital system affiliated with the Weill Cornell Medical College and New York Presbyterian in New York, is consistently named in U.S. News and World Report's "America's Best Hospitals" list. The Methodist Hospital standardized primarily on the Radical, Masimo's fully featured three in one pulse oximeter.
Guy Comeaux, M.D., Chief of Staff, Anesthesiology, spoke of the read-through motion capability of Masimo SET and the transportable design of the Radical. "The best feature is the portability. We have long transits to PACU and ICU. It's a simple matter to carry the Masimo and monitor patients between care sites. Rather than finding a 3 or 4 channel monitor for EKG, BP, oxygenation and other parameters, the Masimo provides, without interruption, oxygenation, heart rate, an indication of heart rhythm disturbance and perfusion index."
Joe Kiani, CEO and Founder of Masimo, stated, "The Methodist Hospital has a rich history of top-level care delivery. The strength of their mission and the excellence they have achieved has extended their influence worldwide. Masimo is proud to provide The Methodist Hospital with the most accurate and reliable pulse oximetry available."
About Masimo Masimo, founded in 1989, is the innovator and leader of read-through motion and low perfusion pulse oximetry. Masimo develops, licenses, and markets advanced medical signal processing technologies and products for the noninvasive monitoring of vital signs. Masimo Signal Extraction Technology, or Masimo SET, represents the standard of care for pulse oximeters. Over 90 clinical studies support the conclusion that Masimo SET is the most effective pulse oximeter in the world. Masimo is headquartered in Irvine, California. Additional information about Masimo and its products can be found at http://www.masimo.com.
Masimo SET Oximetry Now Implemented at Children's Hospital of Orange County (CHOC)
IRVINE, California - August 17, 2004 - Masimo, the innovator and leader of read-through motion and low perfusion pulse oximetry, today announced that Children's Hospital of Orange County (CHOC) and CHOC at Mission has standardized system-wide on Masimo SET oximetry. CHOC provides Orange County's most advanced medical care for children.
Wissy Wallis, Clinical Nurse Specialist (CNS) and Nurse Practitioner (NP) for PICU and Pediatrics at CHOC at Mission, stated, "I believe Masimo pulse oximetry should be the gold standard for pulse oximetry in children. I first experienced Masimo's superb performance at the Pediatric Critical Care Congress in Montreal in June of 2000 and was very impressed with its ability to read accurately through poor perfusion and motion - classic characteristics of our population. What I am most impressed by is the alarm technology. That is the biggest difference Masimo provides, I believe. First, we don't lose alarm settings if we turn the oximeter off and back on so it is accurate and very convenient and user-friendly in that respect. Second and more importantly, there are far fewer false alarms with Masimo." Ms. Wallis continued, "As a CNS and NP it is my job to ensure the best standard of care is provided for our special patient population of infants and children. We are quite happy with our Masimo monitors."
Dan Villareal, RCP, RRT, Director of Respiratory/ECMO Services at CHOC, stated, "The Masimo conversion team is very attentive to the needs of our associates. They presented themselves as professionals and are very knowledgeable of their products. They will go out of their way to ensure that our staff is comfortable with their understanding of the RAD 9, the Radical and their accessories. Needless to say, the house-wide conversion went smoothly thanks to the careful planning, great communication and the incredible clinical inservice team of Masimo. I fully support and recommend Masimo based on our experience."
Joe E. Kiani, founder and CEO of Masimo, stated, "CHOC is a distinguished children's hospital in Southern California, and one of the finest facilities for pediatric and neonatal care in the United States. We are extremely happy and proud to know that if one of our friends or family members needs great neonatal or pediatric care in Orange County, they will be able to get it at CHOC, and they will be monitored safely with Masimo SET pulse oximetry."
Masimo Contact: Brad Langdale (949) 297-7009. email@example.com
Court Enters Final Judgment Against Tyco's Nellcor Division for Infringement of Masimo's Patents
Damage Award Increased to $164 Million
IRVINE, California, August 11, 2004 - Masimo today announced that the District Court for the Central District of California issued its Final Judgment in the patent infringement case between Masimo Corporation and Tyco's Nellcor division. In doing so, the Court finalized the original jury award of $134.5 million for infringements through December 31, 2003. In addition, damages were increased to cover Nellcor's infringement from December 31, 2003 to May 31, 2004. Adding the five additional months of infringement, the damages totaled over $164 million. Damages for any continued infringement after May 31, 2004 will be determined after appeal.
"We are happy that the Court has issued its final judgment upholding the damages award and recognized that Nellcor's continued infringement will result in additional damages," said Joe Kiani, CEO of Masimo. "When we invented and introduced Signal Extraction Technology, inaccurate measurement due to motion artifact was considered an unsolvable problem and an inherent limitation of pulse oximetry. It took an investment of over $90 million to achieve our goal of continuous and accurate monitoring, even during motion and low perfusion. If large companies were allowed to simply use another company's technology without a license, innovation through small companies would stagnate. This final judgment will encourage innovation."
Contact: Brad Langdale Masimo Corporation. firstname.lastname@example.org (949) 297-7009
Masimo Corp. Appoints Rick Fishel to President, Masimo Americas
IRVINE, California - August 3, 2004 - Masimo, the innovator and leader of read-through-motion and low perfusion oximetry, today announced the appointment of Rick Fishel to the position of President, Masimo Americas. Mr. Fishel brings over twenty years of leadership in sales and marketing of state-of-the-art patient care technologies. He has served in a variety of roles over his career, most recently as Regional Vice President of Sales for McKesson Information Solutions after serving as National Vice President of Sales for the Consulting Services division of GE Medical Systems. As a senior-level strategist, he has consistently led sales teams that exceeded sales expectations in addition to building strong partnerships with purchasing groups and distribution networks.
"I'm delighted to join Masimo and continue the remarkable growth in sales and customer satisfaction," stated Rick Fishel. "I first became familiar with Masimo and its breakthrough pulse oximetry technology in its early days while leading a team from MDE that evaluated Masimo SET vs. other technologies. I was thoroughly impressed with its unparalleled performance and, more importantly, its positive impact on patient outcomes. Over the years, I continued to follow the company and have appreciated Masimo's commitment to patient care, the growth of its monitoring excellence and the organization itself. I am excited to be a part of a team that is so committed to helping its customers achieve the patient care and financial objectives that are so vital to their success."
"I am very happy to have Rick Fishel join the Masimo team and take on the responsibility of Americas for Masimo," stated Joe E. Kiani, Chairman & CEO of Masimo Corporation. "Rick is a proven leader with an excellent track record of strategic planning and decision-making. I have known Rick for several years and had the opportunity to work with him well before his joining Masimo. Rick was someone I found to be exceptionally honest, ethical, dedicated and innovative in his approach to making better patient care widely available. I believe with Rick's leadership the Americas team will reach new heights in serving our existing customers and growing our customer base."
Contact: Brad Langdale Masimo Corporation email@example.com (949) 297-7009
Masimo Chief Awarded Forum for Corporate Directors' Director of the Year Award
ORANGE, California - July 22, 2004 - The Forum for Corporate Directors (FCD), a membership of prominent business and community leaders, today announced that Joe E. Kiani, CEO and Chairman of the Board of Masimo, was awarded the 2004 Director of the Year for Corporate Growth designation.
Through its annual Director of the Year Awards, FCD recognizes those directors who have made outstanding contributions to companies in their roles as directors. The other Directors of the year are Dwight W. Decker - chairman and CEO of Conexant Systems, Inc.- Director of the Year for Companies in Transition; Gene Goda, Independent Director - Director of the Year for Economic Value; Henry Samueli, Chief Technical Officer and Chairman of the Board of Directors of Broadcom Corporation - Director of the Year for Corporate Citizenship; Drew Senyei, General Partner and Managing Director of Enterprise Partners - Director of the Year for Early Stage Companies; and Peter Ueberroth, Managing Director of Contrarian Group, Inc. and Owner and Co-Chairman of the Pebble Beach Company - Director of the Year for Corporate Governance.
Sam Yau, Chairman of the Forum for Corporate Directors, stated, "Mr. Kiani built Masimo Corporation from a tiny start-up to a 450+ employee, multinational company that dramatically changed pulse oximetry with their innovation of Masimo SET, a proprietary method of picking up difficult-to-read signals. His leadership also built bridges to Group Purchasing Organizations, paving the way for other small companies to gain access to previously unavailable market segments."
About the Forum for Corporate Directors The Forum for Corporate Director's mission is to promote the highest standards of corporate ethics and best governance practices, create forums for director-peer interactions, and enhance director effectiveness through high-quality and timely education and development programs.
Forum for Corporate Directors membership includes 200 of Orange County's most prominent business and community leaders, corporations, and professional services organizations. Forum members are committed to creating value for their organizations, promoting the highest standards of corporate ethics and sharing their experiences with their fellow members and directors.
Court Upholds $134.5 Million Verdict Against Nellcor for Infringement of Masimo's Patents
Irvine, California, July 16, 2004 - Masimo Corporation today announced that the District Court for the Central District of California upheld a jury verdict against Tyco's Nellcor division of $134.5 million for infringement of Masimo's patents. In doing so, the Court upheld jury findings of infringement for two Masimo patents, with 15 patent claims. The Court also sustained the jury verdict that Masimo did not infringe a Nellcor patent.
The court reversed the jury's finding that the infringement was willful and did not grant an injunction against Nellcor. Further proceedings will determine the additional compensation due Masimo for its losses due to continued infringement. The jury finding of willful infringement would have allowed the court to increase the jury damages award.
The trial involved four patents and 21 claims asserted against Nellcor and one patent and seven claims asserted against Masimo. The jury found infringement against Nellcor on all 21 claims while finding no infringement against Masimo. This ruling by the court leaves an infringement finding against Nellcor on two patents with 15 claims and a damages award of $134.5 million.
"We are pleased that the Court has confirmed that Nellcor has infringed Masimo's patents," said Joe Kiani, CEO of Masimo. "While the Court overturned some findings, in the end, a verdict of infringement of 15 claims is a resounding statement that Nellcor infringed Masimo's patents. Masimo pioneered read-through-motion pulse oximetry, and this ruling confirms Masimo's contribution to the field."
Masimo is currently offering a $250,000 guarantee to hospitals seeking an upgrade to next generation pulse oximetry. If Masimo does not outperform Nellcor in an objective clinical trial, Masimo will pay that hospital $250,000 towards the purchase of Nellcor oximetry. Contact Masimo for more details
Masimo Introduces MS-13 Signal Extraction Oximetry OEM Board
IRVINE, California - July 6, 2004 - Masimo, the innovator and leader of read-through motion and low perfusion oximetry, today announced the release of its new very low power and small outline pulse oximetry circuit board. The MS-13™ occupies only 2 x 2.5 inches of board space and consumes approximately 0.1 watt of power. The MS-13 consumes approximately 1/3 the size and 1/18th the power of Masimo's first OEM printed circuit board, the MS-1™.
The MS-1, MS-3, MS-5, MS-7, MS-11, and MS-13 boards carry the full Masimo SET signal processing algorithm and are sold to Masimo's licensees for incorporation to their patient monitors and therapeutic devices. Once integrated, these instruments give Masimo SET performance with any of the full line of Masimo single patient adhesive or reusable sensors. To date, Masimo has licensed its Signal Extraction pulse oximetry technology to over 35 patient monitoring companies, representing over 70% of the pulse oximetry market. Measuring smaller than a business card, the MS-13 makes the revolutionary motion and low perfusion performance of Masimo SET available in battery operated and very small devices.
Joe E. Kiani, Chairman and CEO of Masimo stated, "Our engineering team has again raised the bar for the betterment of patient care. With the introduction of MS-11 in 2003, we ushered in a new line of monitors for ambulatory patients where reliability, sensitivity and specificity are not sacrificed for battery life or size. MS-13 is even smaller than MS-11, but provides the full performance range of our breakthrough technology. With Masimo SET technology, clinicians can measure pulse rate and arterial oxygen saturation continuously with unprecedented reliability and accuracy, even under motion and low perfusion conditions, and still meet their battery life needs."
Auckland City Hospital, the Largest Hospital in New Zealand, Converts to Masimo SET Oximetry
AUCKLAND, New Zealand - June 29, 2004 - Masimo, the innovator and leader of read-through motion and low perfusion oximetry, today announced that Auckland City Hospital, the largest hospital in New Zealand, has performed a hospital-wide conversion to Masimo SET Oximetry. Auckland City Hospital is the new integrated hospital operated by the Auckland District Health Board. Auckland City Hospital is an amalgam of four hospitals, features over 700 beds, and sees over two million patients per year. Auckland City Hospital has been live with Masimo since it opened its doors in October 2003.
Dr. Nigel Murray, General Manager of Auckland City Hospital, stated, "We are the first hospital in New Zealand to have standardized the use of Masimo SET Oximetry. We believe the sophistication of this technology with its accuracy and reliability will have a major impact on outcomes for patients with poor perfusion and motion. We are pleased with the results so far."
Joe E. Kiani, Chief Executive Officer of Masimo stated, "The acceptance of Masimo Oximetry in the Pacific market demonstrates their attention to the highest standards of patient care. Auckland City Hospital is an engineering marvel and respected center of advanced medicine. We are proud to aid their mission."
About Auckland City Hospital August 2003 saw the first patients into Auckland City Hospital, one of New Zealand's largest public building projects. At 80,000 square meters it is the country's centre of the most advanced acute medical procedures. Construction of Auckland City Hospital was very complex. The Auckland District Health Board, formerly operated four discrete hospitals; Auckland Hospital [acute adult], Starship [acute children's] Green Lane Hospital [cardio-thoracic] and National Women's Hospital [maternity, new-born and gynecology]. Auckland City Hospital is an amalgam of these four hospitals, on a single site in the centre of Auckland city.
Clinical Researchers Find Masimo SET Valuable in Detecting OSA during Overnight Home Oximetry and in the Sleep Lab
IRVINE, California - June 23, 2004 - Masimo, the innovator and leader of read-through motion and low perfusion pulse oximetry, today announced a poster presentation of a new paper at the American Thoracic Society 2004 International Meeting, held May 21-26 in Orlando, Florida, entitled "Utility of a New High Sampling Rate Oximeter and Dip-Rate Software at Diagnosing Moderate-Severe Obstructive Sleep Apnea." This research extends previous work by Dr. Nick Antic, et al., of the Adelaide Institute for Sleep Health in Adelaide, Australia, on the Obstructive Sleep Apnea (OSA)-diagnostic capabilities of Masimo SET.
100 patients aged 18-75 with clinical suspicion of OSA were monitored with a Masimo SET Radical, in FastSat 2-second averaging mode, during one night of overnight home oximetry and a consecutive night of clinical polysomnography. Analysis of the downloaded data reveals excellent correlation between home and lab studies, and little data loss. It was also shown that moderate-severe OSA could be ruled in with confidence (false positive rate of only 4%), with a sensitivity (at the same dip-rate) of 85%. Also, home oximetry was performed well by the patients - in one hundred attempts, there was only one failure of data collection in the home.
Nick Antic, MD, lead researcher of the study, stated, "In our study Masimo oximetry and Stowood scientific dip-rate software have performed very well in the diagnosis of moderate-severe OSA in both the lab (attended) and home (unattended) settings. This means that we can "rule-in" the diagnosis of moderate-severe OSA in 85% of patients with a low false positive rate. The high fidelity signal derived from the Masimo oximeter and SET technology is beneficial in increasing our diagnostic accuracy and maintaining good quality oxygen saturation signal with little movement artifact."
The Medical Center at Bowling Green Converts to Masimo SET Oximetry
BOWLING GREEN, Kentucky - June 16, 2004 - Masimo, the innovator and leader of read-through motion and low perfusion pulse oximetry, today announced that The Medical Center at Bowling Green and its two sister hospitals in Franklin and Scottsville have performed hospital-wide conversions to Masimo SET (Signal Extraction Technology) pulse oximetry. The Medical Center at Bowling Green uses the Masimo SET Radical via SatShare as a stand-alone for bedside monitoring, and the detachable handheld for spot checking saturations during patient assessments.
The Medical Center at Bowling Green compared the Masimo SET Radical and the Nellcor N-595 pulse oximeter side-by-side for eight months and ultimately concluded that the Masimo device would best suit their clinical needs. They cited a markedly stronger pickup of pulse oximetry signals in patients with poor perfusion and increased accuracy across all populations, from neonates to the elderly. Additionally, The Medical Center at Bowling Green, a member of the Premiere Group Purchasing Organization, realized a significant cost savings due to their conversion to Masimo.
Justin Srygler, Director of Respiratory Care, said, "Our decision to implement Masimo was based on its clinically superior performance. It has brought state-of-the-art monitoring technology to our three hospitals. For example, when we do an overnight trending of oxygen saturation, we are finding far less data interruption because of a patient turning over, moving around, etc. It's very helpful in understanding the whole picture."
Mr. Srygler continued, "I had a telling experience during our trial with Masimo. At our sister campus 30 miles away in Scottsville, the Respiratory practitioner was attempting to measure oxygen saturation during ambulation in order to assess a patient for home oxygen therapy, but she was poorly perfused and the clinicians were not getting a pulse oximetry reading from the oximeter they were using. A Masimo Radical was delivered to that campus and a saturation was successfully obtained. It was something we couldn't have done before the Radical."
Joe E. Kiani, founder and CEO of Masimo, stated, "We are glad to be a part of improved patient care at The Medical Center at Bowling Green. The Medical Center at Bowling Green is consistently recognized as a top tier hospital, especially in cardiac care and surgery, where advanced pulse oximetry is so necessary. We look forward to our partnership with The Medical Center at Bowling Green and furthering their mission in providing the best care possible to their patients."
About The Medical Center at Bowling Green The Medical Center at Bowling Green is a 330-bed facility, which has been serving patients for over 76 years. Commonwealth Health Corporation, based in Bowing Green, is the parent company of The Medical Center, and also has facilities in Scottsville and Franklin, Kentucky. The combined facilities offer 512 licensed beds to provide for the healthcare needs of area residents.
Wheaton Franciscan Services, Inc. Converts to Masimo SET Oximetry
WHEATON, Illinois - June 10, 2004 - Masimo, the innovator and leader of read-through motion and low perfusion pulse oximetry, today announced that Wheaton Franciscan Services, Inc. has standardized its pulse oximetry probes and equipment purchases on Masimo SET Oximetry. Pulse oximetry is the noninvasive measurement of arterial oxygen saturation of the blood. It provides indications of respiratory compromise and related vital signs information. Wheaton Franciscan Services, Inc. is the parent organization for more than 100 health and shelter service organizations in Colorado, Illinois, Iowa, and Wisconsin and includes 17 hospital campuses.
Terri Kendrick, director of purchasing for Wheaton Franciscan Services, Inc., said, "The decision to convert to Masimo was multi-faceted, but primarily was focused on anticipated cost savings and improved performance." She explained that the four-hospital region within Wheaton Franciscan Services, Inc. where the new equipment was implemented has realized more than $400,000 in savings on equipment and another $175,000 on supplies. She said, "We look forward to continuing to roll out the equipment across the rest of the organization over the next few months and realize even more savings."
Dale Rose, director of clinical engineering at St. Joseph Regional Medical Center, spoke of the ease of implementation the Masimo team provided. "The implementation was seamless. It was quick, and we did not experience a compromise in safety, confusion among clinicians, or any other adverse disruption in the normal functioning of the hospital. The Masimo team worked very well. People here were well pleased with the process."
Denice Stingl, director of respiratory care and neurodiagnostics at St. Joseph, spoke of the improved performance Masimo SET has brought. "The Masimo technology has proven to be superior to our previous units. We are able to obtain readings on patients with poor peripheral perfusion where our old pulse oximeters could not. The unit is very versatile, and the upgrade team did an awesome job assuring that all the users understood the units and the technology."
Joe Kiani, founder and CEO of Masimo, stated, "Wheaton Franciscan Services, Inc. offers the upper Midwest perhaps the most comprehensive range of health care services available. We are delighted to provide Wheaton with true read-through motion and low perfusion pulse oximetry, and we look forward to their reports of cost savings through sensor reduction and savings in capital expenditures."
About Wheaton Franciscan Services, Inc. Wheaton Franciscan Services, Inc. is a major health care provider in the Midwestern states and is the largest Catholic health care provider in Wisconsin. The organization, which is sponsored by the Wheaton Franciscan Sisters, includes 17 hospital campuses, four long-term care facilities, two home health agencies, 3,500 physicians, 70 clinic sites at which 565 employed physicians practice, 23,700 employees and more than 2,900 units of assisted living and other housing.
University Community Health Converts to Masimo SET Pulse Oximetry
TAMPA, Florida - June 1, 2004 - Masimo, the innovator and leader of read-through motion and low perfusion oximetry, today announced that University Community Health has converted all four of its hospitals to Masimo SET oximetry. Masimo SET (Signal Extraction Technology) offers the highest standard of care in pulse oximetry. University Community Health put much time and energy into choosing this new equipment. "We were looking for a cost effective solution, wanted clinicians to be enthusiastic about the product and we needed to be assured we would receive unparalleled vendor support," explained Glynn Carrigan, Contract Administrator for UC-Health. "Masimo allowed us to achieve all three. They are definitely one of the top three vendors I have worked with in the past 30 years."
Lisa Nummi, Director of Acute Care Services, provides a clinician's perspective, "It is so nice to have a pulse oximeter that gives an oxygen saturation reading we can trust whenever we need it. I have seen the Masimo technology work on patients that would have been very difficult to detect a reading on before. It has made a discernible difference in our ability to care for our patients."
Joe Kiani, CEO of Masimo, stated, "University Community Health is a leader in the medical community. Their record of patient safety and the breadth of services they offer place them in a very elite league. We are honored and proud to bring Masimo SET to their clinicians and patients."
About University Community Health University Community Hospital is part of the University Community Health network of hospitals. The system was created to reflect the combined strength and partnership achieved through the union of University Community Hospital and University Community Hospital-Carrollwood in Tampa, Helen Ellis Memorial Hospital in Tarpon Springs, and Sun Coast Hospital in Largo.
Contact:Brad Langdale Masimo Corporation. firstname.lastname@example.org. (949) 297-7009
Jefferson Regional Medical Center Converts to Masimo SET Oximetry
PINE BLUFF, Arkansas - May 25, 2004 - Jefferson Regional Medical Center (JRMC), a not-for-profit public 470 bed hospital serving South Arkansas, has recently standardized on Masimo SET (Signal Extraction Technology) oximetry hospital-wide. JRMC cited improved monitoring during high motion and poor perfusion, and overall cost-savings, as key reasons for their Masimo conversion.
Dr. Ferdinand K. Samuel, department of Anesthesiology, said, "We decided to use Masimo because our clinicians needed better pulse oximetry for patients with motion and low perfusion. We have been live with Masimo for two months and are happy with its performance. The sensitivity with Masimo is better and the reading is truer."
Joe E. Kiani, Chief Executive Officer of Masimo stated, "We are proud to help JRMC deliver world-class care to the patients of South Arkansas. From geriatrics to radiology, we believe Masimo's breakthrough read-through motion and low perfusion pulse oximetry will contribute to even greater patient outcomes at Jefferson Regional."
About Jefferson Regional Medical Center Licensed for 471 beds, JRMC is the fourth largest hospital in the state of Arkansas. It serves 280,000 residents of 11 South Arkansas counties, supported by a medical staff of approximately 150 physicians representing 30 different specialties.
Welch Allyn To Incorporate Masimo SET Pulse Oximetry Technology Into Future Vital Signs and Patient Monitoring Devices
Next generation pulse oximeter technology - combined with easy-to-use monitoring devices - lead to improved patient care and safety
Irvine, Calif. and Beaverton, Ore. - May 17, 2004 - Welch Allyn, a leading global manufacturer of frontline medical products and solutions, and Masimo Corporation, the innovator of read-through motion and low perfusion pulse oximetry and one of the world's leading providers of pulse oximetry solutions, have extended their relationship to incorporate Masimo technology into future generations of Welch Allyn spot check and patient monitoring product lines. In addition to the Propaq CS and Propaq Encore patient or physiologic monitors, Welch Allyn currently offers Masimo Signal Extraction Technology (Masimo SET) in its Micropaq wireless patient monitor. The new agreement extends through 2010.
"We are very pleased to extend our current business relationship with Masimo and to offer our customers the most advanced pulse oximetry monitoring technology available," said Hans Stover, president of Welch Allyn Monitoring. "Through this agreement, we will have the opportunity to integrate Masimo SET pulse oximetry technology across our extensive lines of patient monitoring systems."
Masimo SET substantially overcomes the limitations of conventional pulse oximeters in accurately measuring arterial blood oxygen saturation levels and pulse rates in the presence of patient movement and low perfusion. The Masimo SET pulse oximetry technology features highly evolved advanced digital signal processing algorithms capable of reading through those conditions most challenging to pulse oximetry: motion combined with low perfusion. Clinicians can expect Masimo pulse oximetry technology to perform substantially better than conventional oximetry for those difficult-to-monitor patients under such conditions.
"This agreement confirms the strength of our business relationship with Welch Allyn and the commitment of both companies to deliver best in class patient monitoring technology," said Joe E. Kiani, Chairman & CEO, Masimo Corporation. "Extending the reach of the Masimo SET pulse oximetry platform through our numerous OEM partners is a testament to the tremendous success of our Signal Extraction Technology."
About Welch Allyn Welch Allyn, Inc. was founded in 1915 and is today a leading manufacturer of innovative medical diagnostic and therapeutic devices, cardiac defibrillators, patient monitoring systems, and miniature precision lamps. Headquartered in Skaneateles Falls, New York, USA, Welch Allyn employs more than 2,300 people and has numerous manufacturing, sales, and distribution facilities located throughout the world. Additional information on Welch Allyn and its products may be found at http://www.welchallyn.com/
About Masimo Founded in 1989, Masimo Corporation, the innovator of motion and low perfusion tolerant pulse oximetry, is a privately held medical technology company that develops, licenses and markets advanced medical signal processing technologies and products for the noninvasive monitoring of patient vital signs. Masimo Signal Extraction Technology, or Masimo SET, represents the standard of care for pulse oximeters. Over 90 clinical studies support the conclusion that Masimo SET is the most effective pulse oximeter in the world. Masimo is headquartered in Irvine, California. Additional information about Masimo can be found at http://www.masimo.com.
Seven New Studies Use Masimo SET, The Gold Standard in Pulse Oximetry, to Research the Advancement of Pediatric
Researchers Use Masimo SET Oximetry to Examine Clinical Practices for Infants
SAN FRANCISCO, California - May 11, 2004 - Masimo, the innovator and leader of read-through motion and low perfusion oximetry, today announced that seven studies reported at the 2004 Pediatric Academic Societies Meeting in San Francisco, California highlight Masimo SET Oximetry as the most reliable and accurate pulse oximeter available.
In a breakthrough study, James Hagadorn MD, et al presented "Actual Versus Intended Oxygen Saturation in Infants <28 weeks Gestation (AVIOx)," i examining the oxygenation practices on Extremely Premature Neonates (EPNs) in neonatal nurseries. Supplemental oxygenation of preterm neonates, while necessary, can lead to excessive or fluctuating oxygen levels, which may contribute to complications of prematurity. An ongoing effort in the research community is aimed at determining the optimal range of supplemental oxygen administration.
The AVIOx study was funded by Fight for Sight/Prevent Blindness America and the NIH-supported General Clinical Research Center at Tufts-New England Medical Center. Dr. Hagadorn's research efforts are funded by a grant from the National Eye Institute.
The presentation examined the consistency of Extremely Premature Neonates' oxygenation, and the compliance of nurses' practice with their nurseries' prescribed oxygenation guidelines at 14 centers in 3 countries, on a population of 85 infants at <28 weeks gestation. The nurseries managed care with their routine pulse oximeters. Masimo SET pulse oximeters were used in the FastSat mode as the control to record what the actual oxygen saturation values were on the neonates.
The researchers found that infants were kept within the intended oxygenation range of their hospitals 45-50% of the time. 35-40% of the time, however, they were kept at oxygenation levels above the intended range. The research points to the need to develop interventions to assist hospitals with successfully achieving their target range.
Dr. Hagadorn, lead author of the study, said, "The results of this study are not really a surprise. Clinicians work hard to avoid both hypoxia and hyperoxia in their patients, but the inherent instability of these severely preterm neonates makes it difficult to achieve narrow oxygenation goals. To the extent that babies can be kept within an optimal oxygenation range, however, we believe that retinopathy of prematurity and other adverse outcomes may be reduced. Developing new methods to help hospitals achieve these goals may thus help improve outcomes for premature infants. And identifying an oxygenation range that will maximize benefit and minimize risk for premature infants is a great priority in the medical community now. It will require a change in how we deliver oxygen therapy to infants." Dr. Hagadorn continued, "The literature supports Masimo as the oximeter that gives the best readings in difficult clinical conditions, which can occur frequently with extremely premature neonates. It's a very helpful research tool for resolving this kind of question."
In addition to Dr. Hagadorn's presentation were two poster presentations that used Masimo SET. Dr. Sun et al investigated nurse practice in attempting to keep oxygen ranges between 80-92%. They found in data collected over a 12-hour shift among 35 nurses that practice varied widely. They found that 62% of the total recorded time was within the target range with 9% in the hyperoxic range of >92% and 7% in the hypoxemic range of < 80%. They concluded, "This study allows us to face the reality of day to day practice of oxygen therapy." ii
Dr. Sahni et al's poster presentation looked at using Perfusion Index (PI) or Pulse Amplitude Index (PAI) to monitor babies in the prone and supine positions. He noted a statistically significant difference between the two positions with the prone position averaging a PI of 3.7 + 0.7 and the supine position averaging a PI of 3.1 + 0.8. He concluded the "prone sleeping position is associated with a higher PI, presumably reflecting thermo-stabilizing adjustments in tissue perfusion in response to relative hyperthermia. Despite adjustments in cardiovascular function, infants remain relatively hyperthermic, suggesting either a move to a higher thermal set point or an impairment of the control system. Such events may have important implications for increased risk for sudden infant death syndrome in prone position."iii
Four abstracts were also published. In one study by Liu et al, Masimo SET oximetry was evaluated for its ability to accurately capture oxygen saturation. They concluded "the SpO2 > 80% was significantly correlated with the SaO2. We were unable to demonstrate an SpO2 bias regressed against the functional SaO2." iv
In another published abstract, a comparative device trial commissioned by Philips Medical Systems, Workie et al tested Masimo SET technology against the Philips FAST pulse oximetry system. The sample population was 36 neonates with a mean gestational age of 32.4 weeks. The researchers concluded that Masimo was "more resistant to motion artifact and demonstrated fewer data dropouts than Philips FAST over time." v
The final two abstracts examined the Perfusion Index (PI) or Pulse Amplitude Index (PAI) of Masimo SET. A study by Dr Zaramella et al found the PI was validated by near-infrared spectroscopy (NIRS). Dr Goldstein et al compared the Neonatal Therapeutic Intervention Scoring System (NTISS), a therapy-driven index of neonatal "sickness," and the Perfusion Index of Masimo SET for correlative significance. They found that lower PI values occurred in infants termed "sick" by the NTISS index (NTISS "sick" infants had a PI of 1.27 + 0.43; NTISS "well" infants had a PI of 1.93 + 0.51). Dr. Goldstein stated that the PI "can be a useful clinical tool in assessing neonatal illness severity." vi
In addition to these studies, Masimo hosted a dinner and lecture by Dr. Augusto Sola of Emory University which was attended by over 200 clinicians The lecture was entitled, "Culture Change in the NICU: Oxygen administration, monitoring, and Retinopathy of Prematurity," and focused on the need to create a culture change in the NICU regarding the oxygenation of premature infants. The talk was derived in part from Dr. Sola et al's study in the February 2003 volume of Pediatrics, "Can Clinical Practice Decrease the Incidence of Severe Retinopathy of Prematurity in Very Low Birth Weight Infants?" vii The paper presents the results of a 5-year study at Cedars-Sinai Medical Center in Los Angeles in which, due to the implementation of an oxygenation protocol for Very Low Birth Weight (VLBW) Infants, the incidence of ROP was reduced from 12-15% to 0% in infants weighing 750 - 1249 g. In infants weighing 500 - 749 g, severe ROP was reduced from 38% to 10-12%. On Monday night, Dr. Sola announced that his colleagues in Atlanta have implemented his protocol at Emory Crawford Long Hospital's NICU and the babies are showing the same encouraging results. Dr. Sola uses Masimo SET for its ability to delivery the most precise oxygenation data, particularly in the case of sick newborns.
Maribeth Sayre, MD, neonatologist and Director of Medical Affairs for Masimo, stated, "These studies demonstrate the usefulness of Masimo SET in assessing neonates and in aiding efforts to change clinical practices in order to improve outcomes. In this conference alone, Masimo SET was specifically noted for its ability to corroborate both blood gases and the NTISS scores for neonatal health. We are especially pleased to see that clinicians are understanding the diagnostic power of PAI, or Pulse Amplitude Index."
Contact:Brad Langdale Masimo Corporation. email@example.com(949) 253-6404.
i Hagadorn J, et al. Actual Versus Intended Oxygen Saturation in Infants <28 weeks Gestation. Late- Breaking Presentation at the 2004 PAS Meeting, San Francisco. ii Sun CS, Stefen E, Vangvanichyakorn K. Validation of prescribed target SpO2 range in ELBW infants: a reality check of nurses' practice. Program Abstract at Pediatric Academic Societies' 2004 Annual Meeting. iii Sahni R, Ammari A, Kashyap S, Ohira-Kist K, De-Guzman C, Schulze KF. Effects of prone vs. supine body position on peripheral perfusion, heart rate (HR), oxygen saturation (SpO2) and thermal profile in growing low birth weight (LBW) infants. Program Abstract at 2004 Academic Societies Annual Meeting. iv Liu WF, Bevins T. Masimo SET pulse oximetry correlation with O2 saturation in the ELBW infant. v Workie FA, Rais-Bahrami K, Short BL. The clinical use of two new generation pulse oximetry (SpO2) devices for patients in the neonatal intensive care unit (NICU). Program Abstract at 2004 PAS Meeting, San Francisco. vi Zaramella P, Ferrari M, Quaresima V, Freato F, G Diego, Chiandetti L. Peripheral perfusion and oxygenation assessment using near-infrared spectroscopy (NIRS) and the oximeter pulsatility index in healthy neonates. Program Abstract at 2004 PAS Meeting, San Francisco. vii Goldstein MR, Lawas-Alejo P, Pernia ML, Furman GI, Sindel BD, Ochikubo CG, Yang LL, Martin GI. Perfusion indicator as a predictor of clinical well-being in the neonatal intensive care nursery. Program Abstract at 2004 PAS Meeting, San Francisco. viii Chow LC, Wright KW, Sola A, and the CSMC Oxygen Administration Study Group. Can changes in clinical practice decrease the incidence of severe retinopathy of prematurity in very low birth weight infants? Pediatrics 2003;111:2.
NCH Healthcare System Implements Masimo SET Oximetry
NAPLES, Florida - April 27, 2004 - Masimo, the innovator and leader of read-through motion and low perfusion pulse oximetry, today announced that the NCH Healthcare System, a 500-bed, 2-campus hospital specializing in cardiac care and oncology, has standardized on Masimo SET oximetry. The NCH conversion features an upgrade of the TRAM and DASH GE patient monitors to full Masimo SET capability, as well as the purchase of nearly 300 Masimo SET Radicals. NCH cited improved care at reduced costs as the principle motivation for conversion.
Scott Wiley, Director, Cardiopulmonary Services, said, "The house-wide conversion to Masimo SET technology was an easy decision for the NCH Healthcare System. It has enabled clinicians to better utilize pulse oximetry. With the motion sensitive technology, perfusion index, and Signal IQ, patient assessment and clinical accuracy has evolved. We now have a clearer understanding of the patient's oxygen saturation status without the guesswork. In terms of the conversion process, it was a committed effort by the Masimo staff. Their team provided us with the support and tools necessary to perform the upgrade."
Kevin Mosher, President, Masimo Americas, stated, "Naples Community Hospital has a reputation for outstanding patient care and a dedication to providing their patients with cutting-edge technology. We believe the 60,000-plus patients they see every year will benefit from the superior signal extraction technology Masimo provides."
About NCH Healthcare System NCH Healthcare is an alliance of more than 550 physicians, 2 hospitals, and dozens of medical facilities in southwest Florida. NCH can be accessed through the internet at http://www.nchmd.org/.
Masimo Announces Clinical Review of Forehead Sensors
Studies suggest forehead oximetry appropriate in limited applications
PARIS, France - April 20, 2004 - Today, at the 13th World Congress of Anesthesia Meeting in Paris, France, Masimo announced the latest study on forehead oximetry and the results of its clinical review investigating the use and clinical viability of forehead pulse oximetry monitoring. Published clinical studies, beginning in 1988, consistently demonstrate a lack of reliability in forehead sensor monitoring. Masimo markets its own pulse oximetry forehead sensor, the TF-I TransFlectance™ sensor, primarily for use as a potential adjunct to traditional sensors, for those patients on whom the digits or ears are not accessible, or in niche applications such as exercise physiology for oxygenation monitoring. Masimo has never marketed its forehead sensor for general-purpose monitoring, and cautions against such use.
In the late 1980s, forehead sensors were introduced with the hope of becoming the general-purpose sensor for oxygenation monitoring. Their application to the forehead promised faster response times in subjects with low peripheral perfusion and a convenient location for anesthesiologists in the operating room. However, clinical studies began showing a fundamental flaw in pulse oximetry measurements on the forehead.
A 1988 study by Eugene Cheng, MD, et al, Department of Anesthesiology, Medical College of Wisconsin, compared the performance of a Criticare Systems' forehead sensor to a digit sensor from the same company. The researchers concluded that the forehead sensor worked well on healthy, well-oxygenated volunteers, but was unreliable when applied to critically ill patients.1
In 1991, Steven J. Barker, PhD, MD, then a professor at University of California, Irvine, reported failure rates for forehead sensors as high as 59% on patients undergoing surgery in a study presented at the Society for Technology in Anesthesia. The same study reported failure rates for finger sensors placed on the same patients at no greater than 1.36%.2
The problems associated with forehead sensors relate primarily to physiology, not technology. When a patient is in the supine or Trendelenberg positions - both very common in the clinical setting - venous blood tends to pool in the head. As the venous system becomes engorged, it pulsates at the same frequency as the arterial blood supply. The pulse oximeter therefore receives a mixed arterial and venous pulsating signal and reports a lower number than the true arterial oxygen saturation. Since the venous pulsation is at the same frequency as the arterial pulsation, even next generation pulse oximeters cannot eliminate it. Conventional pulse oximeters are even worse off with forehead sensors. Not only do conventional pulse oximeters suffer from the venous pulsation problem inherent to all forehead sensors, but also they are more susceptible to gross errors caused by motion since they produce less signal compared to noise.
Beginning in 2002, Tyco-Nellcor reintroduced the forehead sensor and made it their flagship sensor for the new Oximax sensor line, marketing it to clinicians as a general-purpose sensor. The timing of this re-introduction of forehead sensors is close in proximity to the expiration of certain Nellcor sensor patents during 2003. Notably, Nellcor built their latest pulse oximeters, e.g. N595 & N550, to be incompatible with their non-Oximax sensors, and they in turn made their Oximax Max-Fast forehead sensors incompatible with their legacy oximeters, e.g. N200. In attempting to convert the market to their new proprietary Oximax encrypted sensors, Nellcor marketed the Max-Fast forehead sensor as an improvement over traditional pulse oximetry sensors, such as the digit adhesive sensor. Nellcor promoted a 2003 study that suggested that forehead oximetry had improved and warranted Nellcor's marketing of the Max-Fast forehead sensor for general-purpose use. Richard Branson, BA, RRT, FAARC, Associate Professor of Surgery at the University of Cincinnati, et al compared the performance of Nellcor's Max-Fast forehead sensor to a digit sensor on 20 postoperative patients at risk of hypotension and/or hypothermia. Branson reported that the forehead sensor performed 98% of the time over the 26 hours of monitoring.3
On the other hand, the data found in another study by Mr. Branson et al suggested that forehead oximetry had not clinically improved after all. A study was done on 20 trauma patients monitored with both the Nellcor Max-Fast reflectance sensor and the Nellcor Max-A digit sensor with the Nellcor N595 OxiMax pulse oximeter. A total of 73 arterial blood gas-oximeter data pair samples were obtained. Analysis of the study reveals the Max-Fast forehead sensor failed to give reliable readings on 5 of the 20, or 25%, of the patients in the test due to various reasons.4
As new research on forehead oximetry increased, the historic problems continued to resurface and clinical studies discrediting forehead oximetry vastly outnumbered those finding forehead oximetry now useful as a general-purpose oximetry solution.
In an operating room study (see Table 1), Dr. Barker showed that the Nellcor Max-Fast forehead sensor had a percentage error time of almost 28% on 18 patients undergoing surgery. A Masimo SET device with an LNOP TC-I ear sensor demonstrated a percentage error time of 2.5%.5
Aman Mahajan, MD, et al, of the Department of Anesthesiology at UCLA School of Medicine, reported poor performance with the Max-Fast sensor in the adult population. Of the 42 adult surgical patients monitored with the Max-Fast sensor connected to the N-595, 17 (or 40%) showed significant error. In these patients, the Max-Fast sensor displayed a greater than 7% difference in SpO2 than the values of the control pulse oximeters for more than 20% of the surgical case. Dr. Mahajan concluded, "The results of this study suggest that the Max-Fast sensor attached to the N-595 oximeter might not be accurate or reliable enough for use in surgical patients."6
Kirk Shelley, MD, et al., of the Department of Anesthesiology at Yale University, found that the Max-Fast forehead sensor produced corrupt plethysmographic waveforms when used on patients in the supine position. The researchers suggest the presence of an underlying venous waveform is the root cause of this error.7
Daniel Redford, MD, et al, Department of Anesthesiology, University of Arizona in Tucson, reported a performance index of just 71% for the Nellcor N-595 Max-Fast forehead sensor on patients undergoing surgery. Dr. Redford's team also showed significant performance and reliability differences between the Masimo TF-I forehead sensor and the Nellcor N-595 Max-Fast forehead sensor in the Operating Room. The Masimo forehead reflectance sensor performed significantly better than the Nellcor forehead sensor (see Table 2).8
Dr. Redford, the lead author of the study on forehead sensors, stated, "The Nellcor monitor demonstrated an unacceptable use in the surgical patient. The Masimo LNOP TF-I forehead sensor, in contrast, performed with a small bias and precision which was essentially the same as our control finger sensors." Dr. Redford added, "The increased response time of a more centrally located oximeter is welcome and I've seen research demonstrating a successful ear and forehead sensor from Masimo, but anesthesiologists dealing with patients in the clinical environment have better things to do with their time than spend it ruling out falsely low saturations."
In a forehead oximetry study presented this week at the WCA, Dr. Mahajan tested the Max-Fast forehead sensor on a pediatric population and found that poor bias and precision, along with high rates of error, render Max-Fast unacceptable for clinical use. On over half the patients, the Max-Fast erred by greater than 5% for more than 20% of the total operative time. The authors concluded, "…the Max-Fast forehead sensor and the N-595 oximeter is not accurate nor reliable enough for clinical use in pediatric surgical patients." 9
In a second study presented at the WCA conference in Paris this week, Dr. Redford compared the Masimo LNOP TF-I forehead sensors to the TC-I earlobe sensor and showed that the TC-I earlobe sensor worked better than Masimo's own TF-I forehead sensor.10 These results are consistent with Masimo's formal recommendations for earlobe oximetry as the most reliable alternative to traditional sensor sites, such as the digit.
Maribeth Sayre, MD, Director of Medical Affairs of Masimo stated, "Tyco-Nellcor's latest marketing campaign has touted their new forehead sensor as the next big development in pulse oximetry. While quick response time is important to clinicians, the lack of reliability of forehead sensors has been very difficult for manufacturers to overcome. Even though Masimo's LNOP TF-I sensors perform better than Nellcor Max-Fast sensors, we still believe that fingers on adults and the hand, foot, or toe on babies and children provide the most reliable monitoring locations."
Dr. Sayre continued, "There are clear physiological challenges with forehead monitoring, and we strongly suggest their use as an adjunct to the normal sensors or for applications where the patient is upright, such as with exercise physiology. Based on the latest clinical studies, we also believe that, when clinicians want to use the forehead as a monitoring site, they will find greater reliability with the Masimo Transflectance TF-I forehead sensor. We continue to be grateful for researchers testing the marketing claims of devices so directly linked to patient outcomes."
Joe E. Kiani, CEO of Masimo, said, "Masimo understands that this release may not be an exhaustive review of the available clinical literature on forehead oximetry. Until we have such a review, however, we hope this will add to the discussion on alternative monitoring sites. In the interest of patient care, we believe it is imperative that clinicians survey the range of available literature on forehead oximetry and do thorough evaluations of their own before using it routinely in their practice."
1 Cheng EY, Hopwood MB, Kay J. Forehead pulse oximetry compared with finger pulse oximetry and arterial blood gas measurement. J Clin Monit 1988;4:223-226. 2 Barker SJ, Le N, Hyatt J. Failure rates of transmission and reflectance pulse oximetry for various sensor sites. Presented in poster format at the First STA Annual Meeting 1991 . 3 Branson R, Davis B, Davis K, Singh C, Blakeman C, Johannigman J. A comparison of reflective and transmission oximetry in patients with poor perfusion. Resp Care 2003;48. 4 Branson RD, Davis BR, Campbell R, Johannigman J, Davis K. Comparison of a reflective forehead and digit transmission sensor for oximetry in mechanically ventilated adults. Crit Care Med 2003;30:A91. 5 Barker SJ. A clinical comparison of pulse oximetry sensor sites: forehead, earlobe, finger. Presented in poster format at New York Post Graduate Assembly 2003. 6 Mahajan A, Barker SJ. An evaluation of forehead reflectance oximetry in intraoperative surgical patients. Respiratory Care 2003;48. 7 Shelley K, Tamai D, Jablanka D, Gesquiere M, Stout R, Silverman D. The impact of venous pulsation of the forehead oximeter waveform as a possible source of error in SpO2 calculation. Presented in poster format at the STA Annual Meeting 2004. 8 Redford DT, Barker SJ, Lichtenthal PR. Evaluation of 2 forehead reflectance oximeters in intraoperative surgical patients. Presented in poster format at the STA Annual Meeting 2004. 9 Mahajan A, Lee E, Moldovan A. Intraoperative use of forehead reflectance oximetry in pediatric patients. Program abstract at the World Congress of Anesthesiology Annual Meeting 2004. 10 Redford DT, Barker SJ, Lichtenthal PR. Evaluation of 4 new monitoring sites for pulse oximetry in intraoperative surgical patients. Presented in poster format at the World Congress of Anesthesiology Annual Meeting 2004.
Northern California Shriners Hospital Converts to Masimo SET Oximetry
SACRAMENTO, California - April 12, 2004 - Northern California Shriners Hospital for Children, specializing in burns, orthopedic conditions, and spinal cord injury and rehabilitation of children, has standardized on Masimo SET Oximetry. Shriners is a leading research institution and one of the premiere facilities dedicated to the care of pediatric patients. Shriner's Hospitals have never charged fees for their care of their 18 year-old and younger patients. Their conversion to Masimo SET Oximetry follows a side-by-side comparison of Masimo versus Nellcor's pulse oximeters. Administrators cited Masimo's ability to accurately and reliably read through conditions of poor perfusion, where other pulse oximeters couldn't.
Lysa Kinoshita, Manager of Respiratory, said, "I was initially approached by our respiratory care practitioners and nurses about Masimo. They thought it would be a valuable monitor for patients with poor perfusion, so we decided to evaluate Masimo's Radical Signal Extraction Pulse Oximeter. We developed an evaluation form and did a side-by-side comparison of Masimo and Nellcor. Our comparison in the Pediatric ICU really did it for us. We saw that it would give us reliable readings where we'd been losing our oximetry, we liked the capabilities of SatShare, and our clinicians found the handheld portion of the Radical to be very useful in transporting patients."
Ms. Kinoshita continued, "Once the sensor agreement had been approved, the install and inservicing went very well. Masimo provided sufficient technical and educational support before and after the installation and go live date. My perception of Masimo is that they support their product, identify and solve problems. I was confident that when my staff or myself raised concerns, our voice was definitely being heard. We've been live with Masimo for several months and are pleased with its performance."
Kevin Mosher, President of Masimo Americas, stated, "Northern California Shriners Hospital is a bright light in many lives. This is a place children go to become healed, regardless of their ability to pay for it, and we are very proud that Masimo technology has been adopted here. We have created a technology that works where other oximeters fail, and a company philosophy of paying close attention to the needs and desires of the clinical environment. It appears, based on the feedback from Shriners, that our approach is making a difference."
About Shriner's Hospitals Shriners Hospitals for Children Northern California is a JCAHO-accredited medical center providing pediatric care in three specialty programs — orthopaedics, spinal cord injury treatment and rehabilitation, and acute burn treatment and rehabilitation. The hospital is one of 22 Shriners Hospitals throughout North America. Any child under 18 years old may be eligible for admission if the child's condition is within the scope of services offered. All medical care is provided free of charge to the patient and patient family.
The patient and patient's family bear no financial responsibility for care provided at Shriners Hospitals for Children. We do not accept payment for services provided in our hospital. We do not seek reimbursement from the family, insurance companies, or federal/state health programs. The gift of free medical care is made possible by the generosity of many. Donations go to the Shriners Hospitals Endowment Fund, which supports all 22 Shriners Hospitals for Children. If a patient is referred for services our Hospital does not provide, such as urology or outpatient physical therapy, Shriners Hospitals for Children will assist the family in obtaining insurance coverage for these services.
About Masimo Corporation Masimo, founded in 1989, licenses and markets advanced medical signal processing technologies and products for the noninvasive monitoring of vital signs. Masimo Signal Extraction Technology, or Masimo SET, represents the standard of care for pulse oximeters. Over 90 clinical studies have demonstrated that Masimo SET is the most effective pulse oximeter in the world. Masimo is headquartered in Irvine, California. Additional information about Masimo and its products can be found at http://www.masimo.com.
Masimo Becomes Major Southern California Sponsor Of March of Dimes Five-Year Prematurity Campaign
IRVINE, Calif. - April 6, 2004 - Masimo Corporation, the innovator and leader of read-through motion and low perfusion pulse oximetry, and the March of Dimes, one of the largest charitable organizations promoting maternal and infant health, today announced a partnership wherein Masimo will become a major corporate sponsor of Southern California March of Dimes Prematurity Campaign. Based in Southern California, Masimo will concentrate its support in that region.
In reaction to steadily rising rates of prematurity, the March of Dimes has undertaken a five-year national campaign to promote education, funding, and public support in the fight against prematurity. One in 8 babies born in the United States each year is premature and the attendant health problems can be devastating and costly. The campaign is designed to touch everyone involved in the fight against prematurity - from expectant mothers to healthcare practitioners and clinical researchers as well as the general public. The goals of the March of Dimes Prematurity Campaign are to increase the public's awareness of the seriousness of the prematurity problem and to decrease the rate of premature birth in the U.S. by at least 15%.
Fighting prematurity is a natural battle for Masimo. Masimo SET oximetry was prescribed in a groundbreaking patient outcome study on ROP (Retinopathy of Prematurity) as a technology robust enough to measure the precise oxygenation of severely premature infants at risk of ROP. The precision of Masimo SET, according to lead author Dr. Augusto Sola, partly enabled the highly successful implementation of an oxygenation protocol that dramatically reduced the incidence of ROP.
"The rate of premature birth in the U.S. has risen an alarming 29% between 1981 and 2002," said Douglas Cunningham, M.D., chairman of the Southern California Prematurity Campaign. "Prematurity is at near-epidemic proportions, and represents a major healthcare challenge that must be addressed now, and with as many interested organizations working together as possible. We are very grateful that Masimo is willing to be such a strong partner," Cunningham said.
As a Prematurity Campaign sponsor, Masimo played a key role in a three-day conference held in January in Long Beach for over 300 healthcare professionals on "Preventing Birth Defects and Infant Mortality: The Epidemic of Prematurity." Masimo will also be able to directly impact the community as the sponsor of a March of Dimes Community Grant to the Nhan Hon Comprehensive Health Care Clinic of Orange, Calif. The "Healthy Moms, Healthy Babies" program ("Me Tron Con Vuong" in Vietnamese), will work with 200 pregnant Vietnamese women to provide early prenatal health education and support, and to reduce barriers in access to care.
Joe E. Kiani, CEO of Masimo, stated, "The March of Dimes is a powerful instrument of progress. They are an organization with their heart firmly in the right place, and the fight against prematurity is one of the most urgent problems facing the safety and well-being of children worldwide. Masimo is proud to support their endeavors in any way we can."
About March of Dimes The March of Dimes is a national voluntary health agency whose mission is to improve the health of babies by preventing birth defects and infant mortality. Founded in 1938, the March of Dimes funds programs of research, community services, education, and advocacy to save babies and in 2003 launched a five-year campaign to address the increase rate of premature birth. For more information, visit the March of Dimes Web site at marchofdimes.com or its Spanish Web site at nacersano.org.
About Masimo Masimo, founded in 1989, licenses and markets advanced medical signal processing technologies and products for the noninvasive monitoring of vital signs. Masimo Signal Extraction Technology, or Masimo SET, represents the standard of care for pulse oximeters. Over 70 independent and objective, published studies have demonstrated that Masimo SET is the most effective pulse oximeter in the world. Masimo is headquartered in Irvine, California. Additional information about Masimo and its products can be found at http://www.masimo.com.
Johns Hopkins Hospital Implements Masimo SET Oximetry Hospital-Wide
BALTIMORE, Maryland. March 30, 2004. Johns Hopkins Hospital and Masimo, innovator and leader in read-through motion and low perfusion pulse oximetry, today announced the signing of a contract whereby Masimo SET pulse oximetry will be made standard throughout Johns Hopkins. Johns Hopkins is the nation's premier research and care facility, having produced a steady record of breakthrough scientific publications and receiving the U.S. News and World Report's number one hospital ranking for thirteen years running. The conversion follows an evaluation in which Masimo SET was chosen over all other pulse oximetry alternatives based on rigorous performance criteria.
Kevin Mosher, President, Masimo Americas, stated, "Masimo is proud to make Masimo SET oximetry available to the clinicians and patients of Johns Hopkins. The specificity and sensitivity of Masimo SET has not only raised the standard for pulse oximetry, it has also suggested new applications in patient care delivery protocols, as well as the early detection of previously undetected disease, particularly in neonatal care. We believe Masimo SET will aid the clinicians of Johns Hopkins as they continually set new standards of care and make new discoveries in medical science."
About Johns Hopkins Johns Hopkins is one of the world's premier centers for scholarship, research and patient care. The university and The Johns Hopkins Health System are separate, but closely allied, institutions. Founded in Baltimore, they now reach across the Baltimore Washington area, with additional facilities in China, Italy and Singapore and partnerships around the world. The university comprises eight schools, a research and development division called the Applied Physics Laboratory and a number of institutes and centers.
The Health System, which has its origins in the founding of the world famous Johns Hopkins Hospital, now comprises three hospitals, as well as other elements of an integrated system, from a community physicians group to home care. Johns Hopkins Medicine, established in 1995 to unite Hopkins' biomedical research, clinical, teaching and business enterprises, brings together The Johns Hopkins University of School of Medicine and its faculty with the facilities and programs of The Johns Hopkins Health System. The $2.7 billion enterprise is one of the largest employers in Maryland. Its components consistently are named at the top of national rankings for best hospital and best school of medicine, and its faculty consistently win the largest share of NIH research funds. Results of this research continue to advance efforts to diagnose, treat and prevent many diseases.
Masimo Wins Patent Lawsuit Against Nellcor
Jury awards $134 million for Nellcor's patent infringement
Irvine, California, March 26, 2004 - Masimo, the innovator and leader of read-through motion and low perfusion pulse oximetry, today announced that a federal court jury in Los Angeles has found that Nellcor, a division of Tyco Healthcare, should pay Masimo $134,528,960 for Nellcor's infringement of Masimo's patents. Last week the jury had rendered its verdict that Nellcor had willfully infringed four of Masimo's patents on its read-through-motion pulse oximetry technology. After a five-week trial, the jury found all of Masimo's patents in suit valid and infringed. In addition, the jury rejected Nellcor's claim that Masimo's sensor infringed a Nellcor patent.
Joe E. Kiani, Founder and CEO of Masimo stated, "Having sued several years ago, it was a great relief to finally have our day in court, and also to be cleared of all patent infringement accusations made by Nellcor against Masimo."
Masimo, founded in 1989, licenses and markets advanced medical signal processing technologies and products for the noninvasive monitoring of vital signs. Masimo Signal Extraction Technology, or Masimo SET, represents the standard of care for pulse oximeters. Over 70 independent and objective, published studies have demonstrated that Masimo SET is the most effective pulse oximeter in the world. Masimo is headquartered in Irvine, California. Additional information about Masimo and its products can be found at http://www.masimo.com.
Children's Recovery Center Converts to Masimo SET Oximetry
SAN FRANCISCO, California - March 11, 2004 - Masimo, the innovator and leader of read-through motion and low perfusion pulse oximetry, today announced that Children's Recovery Center of San Francisco has converted to Masimo SET oximetry. Children's Recovery Center provides long-term recovery care exclusively for children who are trach/ventilator dependent. Children's Recovery Center cited Masimo's unique ability to provide accurate tracking of oxygenation even during extreme and unpredictable patient motion.
Marla Diamond, COO of Children's Recovery Center, stated, "Our children are all dependent on technology and medically fragile. They are also very active and movement is encouraged. Oxygen monitoring through movement is therefore extremely important to us and we found Masimo to be the best motion-tolerant technology out there. In addition to the motion capabilities, the Radical's removable handheld module will really assist us to provide continuous monitoring as our patients move about our facility. We are excited to begin working with Masimo and the improved monitoring this will afford our patients."
Kevin Mosher, President of Masimo, Americas, said, "Children's Recovery Center is a unique facility with very specialized patients with specific demands. We admire them for making the effort to improve the level of care that they offer their patients and we are delighted that they have chosen Masimo SET for that task."
About Children's Recovery Center Children's Recovery Center is a new and unique pediatric facility, licensed by the Department of Health Services, that provides special high tech, high touch care for medically fragile children. It is state-licensed for pediatric acute and sub-acute care which gives us the flexibility to care for many different types of children. The mission of the Children's Recovery Center is to provide transitional care for children with complex medical, surgical and rehabilitation needs between the acute care hospital setting to the least restrictive most nurturing environment. A family centered environment is provided to all children to promote optimal physical, mental, social and spiritual recovery.
About Masimo Masimo, founded in 1989, licenses and markets advanced medical signal processing technologies and products for the noninvasive monitoring of vital signs. Masimo Signal Extraction Technology, or Masimo SET, represents a fundamental departure from conventional pulse oximetry technologies. Over 70 independent and objective, published studies have demonstrated that Masimo SET is the most effective pulse oximeter in the world. Masimo is headquartered in Irvine, California. Additional information about Masimo and its products can be found at http://www.masimo.com. Masimo is currently offering a $250,000 guarantee to hospitals seeking an upgrade to next generation pulse oximetry. If Masimo does not outperform Nellcor in an objective hospital trial, Masimo will pay that hospital $250,000 towards the purchase of Nellcor oximetry. Contact Masimo Corp. for more details.
Contact: Brad LangdaleMasimo Corporation:firstname.lastname@example.org (949) 253-6404
Masimo Receives FDA 510(k) Clearance for the Rad-5, the First Handheld Pulse Oximeter Incorporating Masimo SET® Oximetry
IRVINE, California. March 3, 2004. Masimo, the innovator and leader in read-through motion pulse oximetry, today announced the release of the Masimo SET® Rad-5™ Handheld Signal Extraction Pulse Oximeter. The Rad-5 incorporates all of the primary features of Masimo's flagship Radical Signal Extraction Pulse Oximeter, but its small size, long battery life, user friendly interface, multiple-day trending and lower cost make it an ideal spot check or continuous monitor for transport, sleep apnea diagnosis, doctor/dental offices and home use.
The Rad-5's long list of features rivals or surpasses most other bedside units. In addition, Rad-5 is equipped with several other Masimo proprietary features that set it apart from the others. FastStart™ allows measurements to be taken quickly after power on. FastSat™ is an optional mode which tracks even brief desaturations, ideal for sleep apnea diagnosis. PAI (Pulse Amplitude Index) tells the clinician the strength of the pulse signal, while SQ (Signal Quality) indicates the quality of the detected signal, alerting the clinician when the signal quality may be compromising the measurement.
Scott Wiley, Director of Respiratory Care at the NCH Healthcare System, Naples, FL. was among the first clinicians to evaluate the Rad-5. He commented, "We sampled the Rad-5 and were very impressed. We look forward to using it regularly. Its power and size will help us in several patient care areas, such as all of our nursing units, our cardiac and pulmonary rehab departments, and we will certainly use it for transport as well. When I sampled the Rad-5, I wanted to be sure it could handle motion and low perfusion like the Radical, and I'm confident that it does."
"The Rad-5 is the result of listening to our customers' wish list," said Joe E. Kiani, founder and CEO of Masimo. "The Radical is a three-in-one pulse oximeter, including a detachable portion that can be used as a handheld. We have seen that many clinicians really find this feature convenient for situations such as transport. For other specific cases, clinicians have expressed interest in a more compact and lower cost handheld unit. Rad-5 extends the utility and reach of Masimo Signal Extraction pulse oximetry."
Masimo Now Offering Hospital-wide Standardization on a Uniform Standard of Patient Care in Pulse Oximetry
Masimo SET and new AC-I adaptor cable make technology and sensor standardization possible
IRVINE, California, February 18, 2004. Masimo Corporation, the innovator and leader in read- through motion pulse oximetry, today announced that recent product introductions make it capable of providing hospitals with technology and/or sensor standardization. With Masimo's unique 3-in-one Radical oximetry solution and broad list of patient monitoring OEM partners, Masimo can standardize a hospital on Masimo SET motion and low perfusion tolerant oximetry at every monitoring site. For hospitals that have not yet upgraded to Masimo's read-through motion oximetry, the Company's new AC-I adaptor cable, recently cleared by the FDA, now enables standardization on Masimo's industry-leading Low Noise Optical Probe (LNOP®) sensors.
Technology standardization allows a hospital to provide a uniform, higher standard of patient care, facilitates clinician training and use of the products, streamlines the materials purchasing process, and reduces costs. Sensor standardization can also be achieved through the AC-I adaptor cable, which enables Masimo LNOP sensors to work on Nellcor compatible pulse oximeters, thus making the technological and value advantages of Masimo's line of LNOP sensors available to nearly every hospital, regardless of the oximetry technology they use.
Joe E. Kiani, founder and CEO of Masimo, said, "Many clinicians and hospital purchasers associate their multiparameter oximetry technology with the sensors they use. In most cases however, while the sensors may be manufactured by Nellcor, the oximetry technology within the monitor is proprietary to the individual multiparameter monitor manufacturer, preventing a uniform standard of care from being delivered to patients. While some clinicians and materials managers are looking for sensor standardization, many others have requested hospital-wide technology upgrade and standardization. Masimo can now provide both. Our sensor design delivers a viable signal, even under the most challenging conditions of poor perfusion or ambient light, and studies have proven the construction of our sensors to be more durable and longer lasting. Studies have shown that standardizing on Masimo technology and sensors can increase patient care and decrease hospital expenditures."
Contact: Brad LangdaleMasimo Corporation:email@example.com ;(949) 253-6404
Children's Hospitals and Clinics Converts to Masimo SET Oximetry
Irvine, Calif. (Feb. 10, 2004) - Masimo, the innovator and leader of read-through motion and low perfusion oximetry technology, today announced that Children's Hospitals and Clinics, the largest hospital system dedicated to pediatric care in the upper Midwest, has standardized on Masimo SET oximetry. Children's - Minneapolis-St.Paul cited Masimo's unparalleled performance, particularly in patients with erratic motion and/or poor peripheral perfusion, common conditions in the pediatric setting, as the reason for their hospital wide conversion to Masimo SET Oximetry.
Children's has made patient safety their flagship objective, earning national honors from the National Quality Forum for their patient safety initiatives. Conversion to Masimo SET oximetry is intended to keep Children's on technology's cutting edge and maximize efforts at maintaining and increasing the safety of their children. Allen Palmer, Site Manager of Respiratory Care at Children's hospital in Minneapolis, cited Masimo's reliable and continuous measurements even on the most poorly perfused and challenging patients. Palmer's team performed extensive side-by-side comparisons of Masimo and other next generation technology, and concluded that with Masimo SET there is a big improvement of monitoring integrity and patient safety.
Kevin Mosher, President, Masimo Americas, stated, "Masimo SET has been shown to be highly effective in pediatric settings. The clinicians and parents of Children's can expect reliable monitoring of their children with Masimo SET. Children's decision to switch to Masimo SET oximetry places them in the elite group of children's hospitals taking advantage of Masimo's superior sensitivity, specificity, fidelity and reliability. We expect a long and rewarding relationship with Children's Hospitals and Clinics due to our mutual mission of improving patient outcome."
About Children's Hospitals and Clinics Children's Hospitals and Clinics is the largest children's health care organization in the upper Midwest, with 299 staffed beds at its two hospitals in St. Paul and Minneapolis. A full range of pediatric specialty services, critical care, and clinics serve premature infants through older teens. While we serve thousands of our region's sick children each year, we also strive to keep children well and to prevent illness and injury. Children's also includes Children's West, an outpatient surgery and rehabilitation center in Minnetonka; Children's - Roseville, an outpatient rehabilitation center in Roseville; and Children's Clinics - Woodwinds, pediatric specialty clinics at the Woodwinds Health Campus in Woodbury.
About Masimo Masimo, founded in 1989, licenses and markets advanced medical signal processing technologies and products for the noninvasive monitoring of vital signs. Masimo Signal Extraction Technology, or Masimo SET, represents a fundamental departure from conventional pulse oximetry technologies. Over 70 independent and objective, published studies have demonstrated that Masimo SET is the most effective pulse oximeter in the world. Masimo is headquartered in Irvine, California. Additional information about Masimo and its products can be found at http://www.masimo.com. Masimo is currently offering a $250,000 guarantee to hospitals seeking an upgrade to next generation pulse oximetry. If Masimo does not outperform Nellcor in a hospital trial, Masimo will pay that hospital $250,000 towards the purchase of Nellcor oximetry. Contact Masimo Corp. for more details.
Contact: Brad LangdaleMasimo Corporation:firstname.lastname@example.org (949) 253-6404
Masimo Announces RadLink And Latest Motion & Low Perfusion Study
Masimo SET provides highest sensitivity and specificity, making Masimo SET with RadLink the ideal pulse oximetry system for hospitals to meet JCAHO's Patient Safety Goal #6
Irvine, California, February 2, 2004 - A new study was presented at the annual Society for Technology in Anesthesia by Steven J. Barker, PhD, MD, Chairman of the Department of Anesthesiology, University of Arizona, Tucson. The latest study by Dr. Barker et al1 compared five of the newest pulse oximeters, including Masimo SET and Tyco-Nellcor N-595, during conditions of combined motion and hypoxemia when used in their fastest response mode (shortest averaging time). Masimo SET V4.1 outpaced others in all tested areas. The following table illustrates Dr. Barker's findings in the areas of Sensitivity (detecting true events) and Specificity (rejecting false events):
"These are the first laboratory experiments to compare the latest 'motion resistant' oximeters in their fastest time-response modes," said Dr. Barker. "Using our standardized motion/hypoxemia protocol, we found a wide range in sensitivity and specificity values. The Masimo Radical performed much better than all four of the other models tested."
RadLink™ RadLink is a wireless paging system designed to give clinicians bedside monitoring access at ranges far beyond the bedside. The name "RadLink" refers to the direct connection of the Radical™ or Rad-9™, Masimo's two standalone pulse oximeters, to a small pager worn by a clinician in the Intensive Care Units, Step Down Units and General Ward. RadLink is easily programmed to page one primary clinician in the event of an alarm, but a default alarm will broadcast to a group of clinicians if the primary page recipient does not respond within a safe period of time. The Joint Commission on Accreditation of Healthcare Organizations, JCAHO, recently passed National Patient Safety Goals aimed at reducing medical error-related deaths. Patient Safety Goal #6 stresses the importance of effective alarms.
"No other pulse oximeter matches the reliability of Masimo SET to detect true alarms and reject false alarms. Combined with RadLink, and Radical's A6, the user-selectable 85-decibel alarm introduced in the 2004 Radical, Masimo is essentially the only pulse oximetry company for hospitals wishing to meet JCAHO's patient safety goals number 6," stated Kevin Mosher, Masimo Americas.
About Steven J. Barker, MD, Ph.D. Dr. Steven Barker obtained his B.S. in Physics (1967) from Harvey Mudd College, followed by M.S. (1968) and Ph.D. (1972) in Engineering Science from the California Institute of Technology, with research in fluid mechanics and aeronautical engineering. After a postdoctoral fellowship at Caltech, he joined the faculty of Mechanics and Structures at UCLA in 1974. He was promoted to Associate Professor of Engineering, with tenure, in 1978. He obtained his M.D. from the University of Miami School of Medicine in 1981. After an internship in general surgery, Dr. Barker served his residency in anesthesiology at the University of California, San Diego. In 1984, Dr. Barker joined the faculty of the Department of Anesthesiology at the University of California, Irvine, where he was promoted to the rank of Associate Professor in 1986 and Professor in 1992. Dr. Barker served as Chairman of Anesthesiology at UC Irvine from 1990 until 1995. In September 1995, Dr. Barker joined the Department of Anesthesiology at the University of Arizona College of Medicine as Professor and Department Head. He also holds a joint appointment as Professor of Mechanical and Aerospace Engineering. Dr. Barker has been elected as chairman of the council of clinical department heads at the University of Arizona (2000-2003). Nationally, he serves as the President of the Association of Anesthesia Program Directors (2001-2003), and Secretary of the Association of University Anesthesiologists. He served as President of the Society for Technology in Anesthesia (1998-99). Dr. Barker is an oral examiner for the American Board of Anesthesiology, and is the Section Editor for Technology, Computing, and Simulation in the journal Anesthesia and Analgesia. Dr. Barker has published 100 scholarly works including 15 book chapters. His recent research is in oxygen transport and monitoring (particularly pulse oximetry), continuous intravascular monitoring, brain function monitoring, and the physics of airway flows and ventilation.
About Masimo Masimo, founded in 1989, is the innovator and leader of motion and low perfusion tolerant pulse oximetry. Masimo develops, licenses and markets advanced medical signal processing technologies and products for the noninvasive monitoring of vital signs. Masimo Signal Extraction Technology represents a fundamental departure from conventional pulse oximetry technologies. Over 70 independent and objective, published studies have demonstrated that Masimo Signal Extraction Technology is the most effective pulse oximeter in the world. To date, Masimo has licensed its Signal Extraction Pulse Oximetry technology to over 35 international patient monitoring system providers, which make up over 80% of the world's pulse oximetry shipments. Masimo is headquartered in Irvine, California. Additional information about Masimo and its products can be found on http://www.masimo.com.
Related studies and copies of Dr. Barker's latest study available upon request from Masimo.
1 Barker SJ, Morgan S. "A Laboratory Comparison of the Newest "Motion-Resistant" Pulse Oximeters During Motion and Hypoxemia." Presented in poster format at the Society for Technology in Anesthesia, January 2004.
Court Rules Masimo Does Not Infringe Yet Another Nellcor Patent
Ruling Marks the Seventh Nellcor Patent Removed From Lawsuit
Irvine, California, January 23, 2004 - The Federal District Court in Los Angeles ruled that Masimo does not infringe another of Nellcor's patents. With this ruling, seven patents, which represent all of the signal processing patents filed against Masimo, have been removed from the case. The case, scheduled for trial in February, will be focused primarily on five of Masimo's signal processing patents. Masimo's suit asserts that Nellcor's latest generation products infringe these patents.
"We have always maintained that Nellcor's assertions of infringement were merely a defensive response to our patent infringement suit filed against Nellcor in 1999," stated Joe E. Kiani, Chief Executive Officer of Masimo. "With all of Nellcor's signal processing patents out of the case, we are able to focus on the main issue of prohibiting Nellcor from infringing Masimo's patents relating to motion and low perfusion tolerant pulse oximeters."
Masimo sued Nellcor, a Tyco Company, in 1999 for infringing Masimo's innovative motion-tolerant pulse oximetry patents. Masimo's claims for patent infringement against Nellcor's Oximax and Oxismart XL pulse oximeters are scheduled for trial in February 2004.
About Masimo Corporation Masimo, founded in 1989, is the innovator and leader of motion and low perfusion tolerant pulse oximetry. Masimo develops, licenses and markets advanced medical signal processing technologies and products for the noninvasive monitoring of vital signs. Masimo Signal Extraction Technology represents a fundamental departure from conventional pulse oximetry technologies. Over 70 independent and objective, published studies have demonstrated that Masimo Signal Extraction Technology is the most effective pulse oximeter in the world. To date, Masimo has licensed its Signal Extraction Pulse Oximetry technology to over 35 international patient monitoring system providers, which make up over 80% of the world's pulse oximetry shipments. Masimo is headquartered in Irvine, California. Additional information about Masimo and its products can be found on http://www.masimo.com.
Masimo Renews its $250,000 Guarantee That Masimo SET Will Outperform Nellcor Pulse Oximeters
The Guarantee Follows New Studies and Numerous Clinical Evaluations Proving Masimo SET® Superior to Nellcor N-595 Oximax Pulse Oximeters
IRVINE, California. January 20, 2004. Masimo, the innovator and leader of motion and low perfusion tolerant pulse oximetry, today announced that it will pay $250,000 towards the purchase of new pulse oximetry equipment if, after a side-by-side clinical comparison, a hospital concludes that Nellcor pulse oximetry technology offers better performance than Masimo SET. This offer is available only to hospitals whose goal is to upgrade their pulse oximetry hospital-wide to Next Generation Pulse Oximetry. Important details, conditions and qualifications for the guarantee are available on Masimo’s web page: http://www.masimo.com.
"We are renewing our $250,000 guarantee to help hospitals and patients,” stated Joe E. Kiani, Chairman and CEO of Masimo. “When we originally launched this guarantee, many clinicians were empowered with the guarantee to convince their institutions to conduct a rigorous evaluation of Masimo SET compared to competing pulse oximeters. These evaluations led to many successful hospital conversions to Masimo SET, benefiting their patients and clinicians. That’s why we thought we should renew our guarantee.”
"Because clinical evaluations can require much time and effort of a hospital and its staff, the $250,000 guarantee is meant to reassure hospitals that rigorously testing manufacturers’ claims is necessary in a field where technological quality is so divergent and the consequences of sub-standard oxygen and pulse rate monitoring can be so devastating to patient care,” stated Kevin Mosher, President of Masimo Americas.
In recent years, over 70 independent and objective, published studies proclaim that Masimo’s technology is more reliable, less prone to false alarms and data dropouts, and more accurate than all of its competitors. On the strength of these studies, response from users, and the 100% success rate in every objective clinical evaluation, Masimo does not hesitate to continue to make such a bold guarantee.
Masimo, founded in 1989, is the innovator and leader of motion and low perfusion tolerant pulse oximetry. Masimo develops, licenses and markets advanced medical signal processing technologies and products for the noninvasive monitoring of vital signs. Masimo Signal Extraction Technology represents a fundamental departure from conventional pulse oximetry technologies. Over 70 independent and objective, published studies have demonstrated that Masimo Signal Extraction Technology is the most effective pulse oximeter in the world. To date, Masimo has licensed its Signal Extraction Pulse Oximetry technology to over 35 international patient monitoring system providers, which make up over 80% of the world's pulse oximeter shipments. Masimo is headquartered in Irvine, California. Additional information about Masimo and its products can be found at http://www.masimo.com.
Brigham and Women's Hospital Implements Masimo SET Oximetry Hospital-Wide
IRVINE, California, January 12, 2004. Masimo, the innovator and leader of motion and low perfusion tolerant pulse oximetry technology, has implemented Masimo SET oximetry at Brigham and Women's Hospital (BWH), a teaching affiliate of Harvard Medical School. BWH selected Masimo's technology to improve oxygen monitoring and enhance the overall quality of patient care.
"Incorporating state-of-the art technology into our clinical setting is a paramount goal for physicians and nurses at BWH," said James Philip, MD, director of Bioengineering, Department of Anesthesiology, Perioperative, and Pain Medicine at BWH. "Following extensive hospital-wide testing and evaluation, we found that Masimo pulse oximetry met the demands of a dynamic academic medical center. Implementing this new technology provides us with a unique opportunity to improve the clinician's work environment and enhance patient care."
Kevin Mosher, President, Masimo Americas, said, "Brigham and Women's Hospital's commitment to excellence in patient care is known throughout the world. We are honored that they have chosen Masimo SET to be part of their process of care."
About Brigham and Women's Hospital BWH is a 725-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare System, an integrated health care delivery network. Internationally recognized as a leading academic health care institution, BWH is committed to excellence in patient care, medical research, and the training and education of health care professionals. The hospital's preeminence in all aspects of clinical care is coupled with its strength in medical research. A leading recipient of research grants from the National Institutes of Health, BWH conducts internationally acclaimed clinical, basic and epidemiological studies.
About Masimo Corporation Masimo, founded in 1989, is the innovator and leader of motion and low perfusion tolerant pulse oximetry. Masimo develops, licenses and markets advanced medical signal processing technologies and products for the noninvasive monitoring of vital signs. Masimo Signal Extraction Technology represents a fundamental departure from conventional pulse oximetry technologies. Over 70 independent and objective, published studies have demonstrated that Masimo Signal Extraction Technology is the safest and most effective pulse oximeter in the world. To date, Masimo has licensed its Signal Extraction Pulse Oximetry technology to over 35 international patient monitoring system providers, which make up over 80% of the world's pulse oximeter shipments. Masimo is headquartered in Irvine, California. Additional information about Masimo and its products can be found on http://www.masimo.com.
Masimo and Philips Announce Broad Long Term Relationship To Offer Masimo SET in Philips Patient Monitors
ANDOVER, Massachusetts, January 7, 2004 - Royal Philips Electronics (NYSE: PHG, AEX: PHI), announced today that its medical systems division, a leader in patient monitoring, and Masimo, a leader of motion and low perfusion tolerant pulse oximetry, have signed a long-term, comprehensive worldwide agreement that will make Masimo SET pulse oximetry available to Philips' patient monitoring customers. A Masimo SET Module for Philips IntelliVue™ monitors was debuted at the American Society of Anesthesiologists annual meeting in October 2003, and is intended to be available for worldwide sale, pending regulatory approval. For the large installed base of Philips CMS and V24/V26 patient monitors, Masimo SET technology is available through a specific Philips VueLink interface module or the Masimo SatShare™ interface. Additionally, Masimo will sell Masimo's LNOP sensors to Philips installed customer base.
"We are very excited to be able to offer our customers the choice of Masimo SET pulse oximetry, said Ken Ferry, senior vice president and general manager, patient monitoring for Philips Medical Systems. "Masimo has pioneered motion and low perfusion tolerant technology and enjoys tremendous support within the clinical and research community. With this agreement, Philips underlines its clinical and technological excellence by offering our customers the widest choice of pulse oximetry technologies and sensors in the patient monitoring industry."
"Philips has a very strong worldwide market presence due to their pursuit of excellence. They are consistently ranked among the top-performing patient monitoring manufacturers, their most recent award being a 'best-of' ranking in over 60 percent of the categories in IMV's customer satisfaction survey performed in the USA," said Joe E. Kiani, Chief Executive Officer of Masimo. "Philips has listened to its customers and has decided to adopt Masimo SET technology as they requested. We are proud to have Philips as a partner in advancing the standard of care."
About Philips Medical Royal Philips Electronics of the Netherlands is one of the world's biggest electronics companies and Europe's largest, with sales of $30.1 billion (EUR 31.8 billion) in 2002. It is a global leader in color television sets, lighting, electric shavers, medical diagnostic imaging and patient monitoring, and one-chip TV products. Its 166,500 employees in more than 60 countries are active in the areas of lighting, consumer electronics, domestic appliances, semiconductors, and medical systems. Philips is quoted on the NYSE (symbol: PHG), Frankfurt, Amsterdam and other stock exchanges. News from Philips is located at www.philips.com/newscenter. ATTN Broadcasters: Philips b-roll (via beta copy, fiber transmission and satellite feed), is available 24/7 by calling (+1-212-375-0021).
About Masimo Corporation Masimo, founded in 1989, is the innovator and leader of motion and low perfusion tolerant pulse oximetry. Masimo develops, licenses and markets advanced medical signal processing technologies and products for the noninvasive monitoring of vital signs. Masimo Signal Extraction Technology represents a fundamental departure from conventional pulse oximetry technologies. Over 70 independent and objective, published studies have demonstrated that Masimo Signal Extraction Technology is the safest and most effective pulse oximeter in the world. To date, Masimo has licensed its Signal Extraction Pulse Oximetry technology to over 35 international patient monitoring system providers, which make up over 70% of the world's pulse oximeter shipments. Masimo is headquartered in Irvine, California. Additional information about Masimo and its products can be found on http://www.masimo.com.
Masimo Launches SPO2.COM Division, Offering Low-Cost Alternatives to Nellcor Pulse Oximetry Sensors
With Savings of 30% and Upgrade Credit to Masimo SET Oximetry
IRVINE, California. January 5, 2004. Masimo, the innovator and leader of motion and low perfusion tolerant pulse oximetry, today announced the launch of SPO2.COM™, a new division that manufactures and markets pulse oximetry sensors for conventional Nellcor-sensor-compatible pulse oximeters. SPO2.COM sensors are offered at a significantly lower cost than Nellcor sensors and, in addition, the purchase of SPO2.COM sensors earns valuable credits for use in upgrading to Masimo SET technology. See http://www.spo2.com/ for details.
SPO2.COM produces a full line of low-cost pulse oximetry sensors and patient cables for use with conventional Nellcor-sensor-compatible pulse oximeters. The sensors, although similar to conventional sensors, incorporate the Masimo-patented LNOP® recessed photo detector for greater motion, electrical, and ambient light rejection. Laboratory testing of the SPO2.COM sensors has demonstrated a higher resistance to ambient light and electromagnetic interference (EMI) when compared to the Nellcor Oximax, Oxisensor II and Oxicliq sensors. The full line of SPO2.COM sensors is now available at http://www.spo2.com/ or through SPO2.COM authorized distributors.
Kevin Mosher, President, Masimo Americas, stated, “We recognize that those hospitals using conventional pulse oximetry still have the need to upgrade to next generation pulse oximetry, so we developed a vehicle to reduce the cost of this upgrade through SPO2.COM sensors. Customers can immediately realize operational savings of 30% with SPO2.COM sensors, and they can also earn valuable credits toward the purchase of Masimo SET oximetry products every time they buy SPO2.COM sensors.”
About SPO2.COM SPO2.COM, established in 2003, offers pulse oximetry sensors for conventional Nellcor-sensor-compatible pulse oximeters.
About Masimo Corporation Masimo, founded in 1989, is the innovator and leader of motion and low perfusion tolerant pulse oximetry. Masimo develops, licenses, and markets advanced medical signal processing technologies and products for the noninvasive monitoring of vital signs. Masimo Signal Extraction Technology represents a fundamental departure from conventional pulse oximetry technologies. Over 70 independent and objective, published studies have demonstrated that Masimo Signal Extraction Technology is the safest and most effective pulse oximeter in the world. To date, Masimo has licensed its Signal Extraction Pulse Oximetry technology to over 35 international patient monitoring system providers, which make up over 70% of the world's pulse oximeter shipments. Masimo is headquartered in Irvine, California. Additional information about Masimo and its products can be found on http://www.masimo.com.
Masimo, Masimo SET, Signal Extraction Technology, SPO2.COM, and LNOP are trademarks of Masimo Corporation. Nellcor, Oximax, Oxisensor, and Oxicliq are trademarks of Tyco/Nellcor.