Masimo Receives FDA Clearance for Noninvasive Total Hemoglobin

IRVINE, Calif. , May 14 /PRNewswire-FirstCall/ -- Masimo, the inventor of Pulse CO-Oximetry(TM) and Measure-Through Motion-and-Low-Perfusion pulse oximetry, today announced it has received FDA clearance for its breakthrough noninvasive and continuous total hemoglobin monitoring technology (SpHb(TM)). The availability of Masimo SpHb technology should make hemoglobin measurement more convenient and broadly available to clinicians in both hospital and outpatient settings -- helping them make earlier and better clinical decisions, improve patient safety and decrease costs. Noninvasive total hemoglobin will be offered as part of the upgradable Masimo Rainbow SET technology platform.

Ronald Miller , MD, Professor and Chair of the Department of Anesthesia and Perioperative Care at the University of California at San Francisco (UCSF) stated, "Management of appropriate blood levels is vitally important to sustain life. Without up-to-date hemoglobin levels, patient bleeding in the operating room, recovery room, intensive care or trauma departments -- where blood loss is common -- can often go undetected until it poses critical short and long-term dangers to health and recovery. The ability to immediately and continuously measure hemoglobin levels will facilitate the timely administration of appropriate blood products. Conversely, during surgery, because blood is a precious and costly resource, continuously measuring hemoglobin levels noninvasively can help clinicians avoid unnecessary blood transfusions and decrease costs by more effectively titrating blood and blood replacement products."

Joe E. Kiani , Chairman and CEO of Masimo, said, "Developing breakthrough technologies that enhance patient safety and automate patient care is a responsibility that we take seriously. With noninvasive hemoglobin as part of the upgradable Masimo Rainbow SET platform, we are proud to be revolutionizing the way clinicians can assess anemic status and make more timely decisions that affect millions of patients worldwide."

The need for better hemoglobin monitoring to manage blood levels is reinforced by recently published controlled studies that show the safety of blood transfusions can be improved by the use of transfusion thresholds. In a 2008 study by the Cochrane Collaboration titled Transfusion Thresholds and Other Strategies for Guiding Allogeneic Red Blood Cell Transfusion, reviewers examined evidence from ten trials -- reporting outcomes on a total of 1,780 patients -- and found that "restrictive transfusion strategies reduced red blood cell transfusions by 42%."

Additionally, while noting that not all of these results were statistically significant and that additional studies are required to confirm the findings, the Cochrane reviewers also reported that, "on average, mortality was 20% lower with the restrictive compared with the liberal transfusion triggers." Similarly, five of the ten studies examined showed a reduction in hospital length of stay, while three showed a reduction in ICU length of stay. (1)

Continuous, noninvasive hemoglobin monitoring with Masimo Rainbow SET SpHb may enable more restrictive transfusion triggers and help maintain optimal hemoglobin levels for critically-ill patients. In addition to facilitating better blood level management, Masimo Rainbow SET's noninvasive hemoglobin monitoring capability should also help clinicians better manage chronic anemia, a blood disorder affecting two billion people worldwide that is one of today's most prevalent public health problems. Masimo Rainbow SET SpHb should provide hospitals, emergency medical professionals, dialysis centers, family physicians, cardiologists, pediatricians and other care providers with a more convenient and accessible way to manage this pervasive condition.