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.
More than 350 million invasive hemoglobin lab tests are performed each
year in the U.S. alone, making it one of the most common laboratory tests.
Hemoglobin lab tests are costly, time-consuming and require that clinicians
use a needle to draw a patient's blood -- however, they only provide delayed
and intermittent data. Masimo's SpHb technology requires no invasive
procedures and provides continuous, real-time, pain-free results. This should
allow clinicians to perform fewer lab tests, better manage blood transfusions
and hemodialysis procedures, speed detection of internal bleeding, and more
efficiently assess chronic anemia -- all of which should help improve patient
outcomes and reduce the cost-of-care.
"No other technology can provide continuous, noninvasive hemoglobin
measurements," stated Michael O'Reilly, MD, Executive Vice President of
Medical Affairs at Masimo. "Masimo Rainbow SET SpHb has the potential to
revolutionize the management of both acute and chronic anemia, as well as the
therapeutic interventions used to treat these conditions. We believe SpHb
will provide a significant advancement in patient safety for clinicians
worldwide."
The Masimo Rainbow SET platform allows clinicians to noninvasively and
continuously measure oxygen content (SpOC(TM)), carboxyhemoglobin (SpCO(R)),
methemoglobin (SpMet(R)), PVI(TM) and total hemoglobin (SpHb(TM)), in addition
to oxyhemoglobin (SpO2), perfusion index (PI), and pulse rate (PR). Masimo
anticipates commercial availability for both SpHb and SpOC in Q3 2008 to
select customers.
About Masimo
Masimo (Nasdaq: MASI) develops innovative monitoring technologies that
significantly improve patient care-helping solve "unsolvable" problems. In
1995, the company debuted Measure-Through-Motion-and-Low-Perfusion pulse
oximetry, known as Masimo SET, which virtually eliminated false alarms and
increased pulse oximetry's ability to detect life-threatening events. More
than 100 independent and objective studies demonstrate Masimo SET provides the
most reliable SpO2 and pulse rate measurements even under the most challenging
clinical conditions, including patient motion and low peripheral perfusion. In
2005, Masimo introduced Masimo Rainbow SET, a breakthrough noninvasive blood
constituent monitoring platform that can measure many blood constituents that
previously required invasive procedures. Rainbow SET continuously and
noninvasively measures total hemoglobin (SpHb(TM)), oxygen content (SpOC(TM)),
carboxyhemoglobin (SpCO(R)), methemoglobin (SpMet(R)), and PVI(TM), in
addition to oxyhemoglobin (SpO2), pulse rate (PR), and perfusion index (PI),
allowing early detection and treatment of potentially life-threatening
conditions. Founded in 1989, Masimo has the mission of "Improving Patient
Outcomes and Reducing Cost of Care by Taking Noninvasive Monitoring to New
Sites and Applications." Additional information about Masimo and its products
may be found at http://www.masimo.com.
Forward Looking Statements
This press release may include forward-looking statements. These
forward-looking statements are based on current expectations about future
events affecting us and are subject to uncertainties and factors, all of which
are difficult to predict and many of which are beyond our control, including:
risks related to our assumption that Masimo's new noninvasive
measurements -- total hemoglobin (SpHb(TM)) and oxygen content (SpOC(TM)) --
will deliver a sufficient level of clinical improvement over alternative
hemoglobin measurement capabilities to allow for rapid adoption of the
technology and risks related to our assumptions regarding the timing or
commercial availability of SpHb and SpOC, as well as other factors discussed
in the "Risk Factors" section of our quarterly report on Form 10-Q for the
quarter ended March 29, 2008, filed with the Securities and Exchange
Commission on May 1, 2008. Although we believe that the expectations reflected
in our forward-looking statements are reasonable, we do not know whether our
expectations will prove correct. You are cautioned not to place undue reliance
on these forward-looking statements, which speak only as of the date hereof.
We do not undertake any obligation to update, amend or clarify these forward-
looking statements or the risk factors contained in our quarterly report on
Form 10-Q for the quarter ended March 29, 2008, whether as a result of new
information, future events or otherwise, except as may be required under the
federal securities laws.
(1) Hill SR, Carless PA, Henry DA, Carson JL, Herbert PC, McClelland DBL,
Henderson KM. Transfusion thresholds and other strategies for guiding
allogeneic red blood cell transfusion. Cochrane Database of
Systematic Reviews 2000, Issue 1. Art. No.: CD002042. DOI:
10.1002./14651858.CD002042.
Contact: Dana Banks
Masimo Corporation
949-297-7348
Masimo, SET, Signal Extraction Technology, Improving Outcomes and
Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and
Applications, Rainbow, SpHb, SpOC, SpCO, SpMet, PVI, Radical-7, Rad-87,
Rad-57, Rad-9, Rad-8, Rad-5, Pulse CO-Oximetry and Pulse CO-Oximeter are
trademarks or registered trademarks of Masimo Corporation.
SOURCE Masimo Corporation