Noninvasive Hemoglobin Receives Rave Reviews from Attendees at Masimo's
Commercial Exhibit
IRVINE, Calif., March 6 /PRNewswire-FirstCall/ -- Masimo, the inventor of
Pulse CO-Oximetry(TM) and Measure-Through Motion and Low Perfusion pulse
oximetry, reported that multiple clinical studies demonstrating the accuracy
and clinical effectiveness of the Masimo Rainbow SET platform were highlighted
earlier this week to over 8,000 anesthesiologists at the 14th World Congress
of Anesthesiology (WCA) in Cape Town, South Africa. In addition, WCA
attendees from all over the world were able to preview noninvasive total
hemoglobin (SpHb(TM)) and oxygen content (SpOC(TM)) as part of the Rainbow SET
platform (pending FDA clearance).
Clinical Study Highlights
Continuous Noninvasive Measurement of Hemoglobin via Pulse CO-Oximetry(1),
a clinical study led by Dr. Mark Macknet at Loma Linda University in Loma
Linda, California, presented a study that compared an engineering prototype of
Masimo Rainbow SET noninvasive total hemoglobin (SpHb) to invasive laboratory
hemoglobin measurements in two groups. Group one included 55 patients
scheduled to undergo surgery, while group two consisted of 32 healthy
volunteers undergoing a hemodilution protocol. After reviewing 1,538 data
pairs, researchers found that the Masimo technology accurately delivered total
hemoglobin levels, with the study showing accuracy of 1.28 mg/dl and
0.94 mg/dl for group two, respectively, when compared to invasive laboratory
CO-Oximetry. Researchers concluded that Masimo's device is the "first device
developed that can continuously and noninvasively measure hemoglobin
concentration, in addition to the other common hemoglobin species, and
therefore provides a significant expansion of existing physiologic monitoring
technology."
Casual Screening of Hemoglobin Noninvasively Positively Affects a
Colleague's Future(2), a case report by Dr. Martin Allard at Loma Linda
University recounted the application of SpHb to assess an anemic hemoglobin
level of 10.6 g/dl on a fellow anesthesiologist who otherwise appeared
healthy. Invasive hemoglobin testing confirmed the measurement and further
diagnostic testing revealed previously undiagnosed and asymptomatic esophageal
cancer. Researchers concluded that Masimo SpHb allowed the "detection of this
potentially devastating tumor before clinical signs or symptoms became
apparent, which resulted in early intervention and therapy that may well be
curative for this colleague."
New Pulse Oximetry Sensors with Low Saturation Accuracy Claims(3),
performed by Dr. Peter Cox at the Hospital for Sick Children in Toronto,
Canada, evaluated 12 patients with congenital cyanotic cardiac lesions (CCCL)
to compare noninvasive oxyhemoglobin (SpO2) measurements from the Masimo
Rainbow SET Radical 7 device with Blue Sensor and the Covidien N-600 device
(OxiMax with Lo-Sat) to invasive oxyhemoglobin levels from laboratory
CO-Oximetry. Although the Nellcor N-600 with LoSat is advertised to work in
CCCL patients, the accuracy demonstrated in this study was 6.49%, well outside
of Nellcor's published specifications. In contrast, the Masimo Radical with
Blue Sensor, the first and only sensor with accuracy claims cleared for
cyanotic patients, performed within Masimo specifications and had
significantly better accuracy at 3.85%. Study results demonstrate that the
Masimo Blue sensor, which was "designed for use specifically in this patient
population, is more accurate." Dr. Peter Cox, Hospital for Sick Children in
Toronto, Canada, said, "Accurate monitoring of oxygen saturations in children
with cyanotic congenital heart defects is essential for appropriate patient
management and, therefore, its impact on their long-term outcome. The Masimo
Blue Sensor accurately tracks saturation to levels as low as 60%, which will
greatly assist caregivers in the management of this patient population."
Severe Methemoglobinemia Detected by Pulse CO-Oximetry in the Operating
Room(4), a case report by Dr. Steven J. Barker and Dr. E. H. Annabi at the
University of Arizona in Tucson, Arizona, documented the use of Masimo
noninvasive methemoglobin (SpMet(R)) to accurately diagnose a severe case of
drug-induced methemoglobinemia and subsequently monitor and guide the
patient's treatment and recovery. Researchers concluded that Masimo SpMet can
"quickly diagnose" methemoglobinemia in the perioperative setting, where time
is of the utmost essence.
Commercial Exhibit Highlights
Masimo also previewed, for the first time, continuous noninvasive total
hemoglobin (SpHb) and oxygen content (SpOC) as part of the Rainbow SET
platform during WCA's commercial exhibition. In the first five hours alone,
an astounding number of over 1,000 anesthesiologists visited the booth and
experienced first-hand product demonstrations and clinical presentations of
the new SpHb and SpOC parameters, along with Masimo's measure-through motion
and low perfusion pulse oximeters. Scores of anesthesiologists who perform
invasive hemoglobin testing routinely during surgery were amazed by the
ability to get their own hemoglobin levels tested noninvasively in just
seconds. In fact, anesthesiologists were heard proclaiming "this changes
everything" and "noninvasive hemoglobin will revolutionize anesthesiology!"
"The new clinical evidence for Masimo Rainbow SET and preview of SpHb and
SpOC were extremely well-received by anesthesiologists from around the world
at the WCA," stated Joe E. Kiani, Founder and CEO of Masimo. "We are proud to
once again revolutionize noninvasive monitoring for the benefit of patient
care."
Michael O'Reilly, MD, EVP of Medical Affairs at Masimo, stated,
"Noninvasive total hemoglobin represents an exciting and valuable expansion of
the noninvasive hemodynamic capabilities available to anesthesiologists. Many
of whom remarked that the ability to see total hemoglobin and oxygen content
measurements, along with carboxyhemoglobin (SpCO(R)), methemoglobin (SpMet),
pleth variability index (PVI(TM)), perfusion index (PI), oxygen saturation
(SpO2) and pulse rate -- all on one screen, with one device and one sensor,
was equally impressive."
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, and with it 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 trustworthy SpO2 and pulse rate measurements even under the most
difficult 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
pleth variability index (PVI(TM)), in addition to oxyhemoglobin (SpO2),
perfusion index (PI) and pulse rate, 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 testing 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, and will be timely cleared, if ever, by
appropriate regulatory bodies, as well as other factors discussed in the "Risk
Factors" section of our annual report on Form 10-K for the year ended December
29, 2007, filed with the Securities and Exchange Commission on March 4, 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 annual report on Form 10-K for
the year ended December 29, 2007, whether as a result of new information,
future events or otherwise, except as may be required under the federal
securities laws.
(1) Continuous Noninvasive Measurement of Hemoglobin via Pulse
CO-Oximetry. Mark R. Macknet, Penny L. Kimball-Jones, Richard L.
Applegate, Robert D. Martin, Martin W. Allard. Anesthesiology, Loma
Linda University, Loma Linda, CA.
(2) Casual Screening of Hemoglobin Noninvasively Positively Affects a
Colleague's Future. Martin Allard, John Viljoen, Mark Macknet.
Anesthesiology, Loma Linda University, Loma Linda, CA.
(3) New Pulse Oximetry Sensors with Low Saturation Accuracy Claims. Peter
Cox. Department of Critical Care Medicine, Hospital for Sick Children,
Toronto, Canada.
(4) Severe Methemoglobinemia Detected by Pulse CO-Oximetry in the
Operating Room. S. J. Barker, E.H. Annabi. Anesthesiology, University
of Arizona, Tucson, AZ.
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, and Pulse CO-Oximeters are trademarks
or registered trademarks of Masimo Corporation.
SOURCE Masimo Corporation
CONTACT: Dana Banks of Masimo Corporation, +1-949-297-7348
Web site: http://www.masimo.com