
Masimo Initiates Full Market Release of First-Ever Noninvasive Continuous Hemoglobin Monitor
Success in Limited Market Release Hospitals Highlights Early Clinical Benefits and Patient Impact
Irvine, California – March 24, 2009 – Masimo (NASDAQ: MASI), the inventor of Pulse CO-Oximetry™ and Measure-Through Motion and Low-Perfusion pulse oximetry, announced today that it has initiated the full market release of its breakthrough noninvasive and continuous hemoglobin (SpHb™) monitoring technology. As the first noninvasive and continuous hemoglobin monitoring technology to receive FDA 510(k) clearance and be available for widespread commercial adoption, Masimo SpHb is already transforming the way hemoglobin testing is performed at over 40 hospitals in the U.S., Europe, Asia, and Africa, that have participated in the technology's limited market release initiated in September of 2008.
The availability of noninvasive, continuous, and immediate hemoglobin measurements is expected to have wide ranging clinical impact, from surgery and intensive care to less acute care settings, including the emergency department, physician office, ambulatory surgery center, and long-term care facility by facilitating prompt detection of internal bleeding and more appropriate administration of blood transfusions. Early benefits and impact of Masimo SpHb were evident in feedback received from clinicians at hospitals around the world who participated in the limited market release.
Ronald Miller, MD, Chief of Anesthesia, Professor and Chairman of the Dept. of Anesthesia and Perioperative Care at the University of California, San Francisco, stated, "Masimo SpHb is an impressive new tool that helps us to more safely guide patients in surgery through to recovery. With it, not only can we spot hemoglobin changes as they occur, but we can see where they are heading. This ability to identify an upward or downward hemoglobin trend on a second-by-second basis as it occurs has been of tremendous value."
Randy Marcel, MD, Medical Director and Chief of Anesthesiology at The Heart Hospital Baylor Plano in Plano, Texas, stated, "In the past, we've only received glimpses of our patients' hemoglobin levels from lab measurements, but now we have complete and real-time hemoglobin visibility. We initially purchased SpHb for use during cardiac surgeries in the OR, and brought in additional units for the ICU, where post-operative monitoring of internal bleeding is critical to patient recovery."
Javed Akhtar, MD, FAAP, Medical Director, Pediatric Intensive Care Unit at Creighton University Medical Center in Omaha, Nebraska, stated, "We purchased the SpHb monitor after seeing it in a hands-on demonstration, and I'm glad we did! SpHb has reduced the traumatic experience for pediatric patients, increased the satisfaction of parents, and reduced the workload on our nursing staff, phlebotomist and laboratory personnel."
Madhava Karunarathna, MD, OB/GYN at Balangoda Hospital in Sri Lanka, stated, "With SpHb, we now have accurate hemoglobin measurements available at our fingertips, around the clock. In cases of severe hemorrhaging during and after childbirth, SpHb has enabled us to immediately identify and continuously assess blood loss severity to better manage internal bleeding, prevent overloading of fluid, and decrease maternal death."
Adi Abdussalam Adham, MD, Chief Manager at Accidents Hospital Abu Saleem in Tripoli, Libya reinforced Dr. Karunarathna's comments, adding that: "In the operating room, Masimo SpHb has enabled us to more effectively monitor blood loss and better manage transfusions in surgery, while routine screening in the ED has helped us to more rapidly identify patients with anemia or internal bleeding."
Bertrand Debaene, MD, Anesthesiologist at the University Hospital Center of Poitiers in Poitiers, France believes the combination of SpHb and PVI may prove to have significant clinical benefits, saying that "SpHb, along with PVI, have been important improvements for both the department and our patients. The ability to track hemoglobin and fluid volume in real-time allows us to be more precise in our clinical routine."
SpHb is part of the Masimo Rainbow SET Pulse CO-Oximetry patient monitoring platform—the first-and-only upgradable technology platform capable of continuously and noninvasively measuring multiple blood constituents and helping to predict fluid responsiveness in patients previously requiring invasive procedures. Masimo Rainbow SET noninvasive measurements—including: total hemoglobin (SpHb™), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), PVI™, oxyhemoglobin (SpO2), pulse rate (PR), and perfusion index (PI)—have the potential to facilitate faster, easier and safer health decisions.
Currently available in bedside Masimo Radical-7® and Rad-87® Pulse CO-Oximeter patient monitors, SpHb will also be offered in handheld monitors and select multiparameter patient monitoring brands through Masimo Rainbow SET Pulse CO-Oximetry technology license agreements.
Joe Kiani, Founder and CEO of Masimo said, "SpHb's success during the limited market release phase at hospitals around the world illustrates its expected significant impact on clinical practice and patient care. In addition and as we expected, our limited market release program provided us with the opportunity to enhance the robustness in low perfusion situations and broaden the cross section of individuals on which the technology performs. The ability for clinicians in hospitals, private practices, and other healthcare settings to perform immediate and continuous noninvasive hemoglobin monitoring creates new opportunities to save lives, optimize decision making, improve care, and reduce costs."
SpHb has received regulatory clearance in the U.S., Canada, Europe and Australia, and is now available for sale in most of the countries in the world.
Contact:
Dana Banks
Masimo Corporation
949-297-7348
