Masimo Receives FDA Clearance for Noninvasive Total Hemoglobin Adhesive
Sensors
IRVINE, Calif., Sept. 15 /PRNewswire-FirstCall/ -- Masimo (Nasdaq: MASI),
the inventor of Pulse CO-Oximetry and Measure-Through-Motion-and-Low-Perfusion
pulse oximetry, today announced limited release of its noninvasive and
continuous hemoglobin (SpHb(TM)) and oxygen content (SpOC(TM)) monitors,
Radical-7 and Rad-87. Masimo also announced the FDA 510(k) clearance of its
latest Rainbow family of adhesive sensors capable of noninvasively measuring
total hemoglobin and oxygen content, along with oxygen saturation (SpO2),
pulse rate, pleth variability index (PVI), and methemoglobin (SpMet(R)), for
use with Masimo Rainbow SET-enabled devices.
The limited release of Masimo Radical-7 and Rad-87 Pulse CO-Oximeters with
noninvasive and continuous total hemoglobin technology will allow select
hospitals around the world to be the first to pioneer a breakthrough
technology that may make it safer, faster, and easier for healthcare
professionals to measure hemoglobin -- without removing a drop of blood.
Hospitals purchasing noninvasive hemoglobin devices and selected for the
limited product release will work closely with Masimo to implement the
technology in their facilities and provide data on its impact on patient care.
"Current methods for measuring total hemoglobin are invasive and only
offer delayed and intermittent results," stated Joe E. Kiani, Masimo Chairman
and CEO. "We look forward to working closely with the first customers of our
noninvasive hemoglobin monitoring technology to enable earlier and better
clinical decisions, improve patient safety, and decrease costs."
Today, hemoglobin is one of the most commonly-performed clinical
laboratory tests with more than 400 million performed annually in the U.S.
alone. A low hemoglobin level is called anemia, a pervasive blood disorder
that according to the World Health Organization (WHO) affects two billion
people worldwide and causes one million deaths a year. Anemia can be chronic
or acute. Chronic anemia is characterized by consistently low hemoglobin
levels that can be the result of a diet deficiency, or illness such as cancer.
Acute anemia is characterized by a sudden drop in hemoglobin levels that can
result from internal or external bleeding due to surgery or trauma.
Masimo noninvasive total hemoglobin (SpHb(TM)) and oxygen content
(SpOC(TM)) are part of Masimo Rainbow SET Pulse CO-Oximetry, the first and
only technology platform to noninvasively measure blood constituents and fluid
responsiveness that previously required invasive procedures. In addition to
hemoglobin and oxygen content, Rainbow measurements include: carboxyhemoglobin
(SpCO(R)), methemoglobin (SpMet(R)) and Pleth Variability Index (PVI) -- in
addition to the 'Gold Standard' measure-through-motion-and-low-perfusion
performance of Masimo SET Oxygen Saturation (SpO2), Pulse Rate (PR) and
Perfusion Index (PI).
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 Pulse CO-Oximetry, a
breakthrough noninvasive blood constituent monitoring platform that can
measure many blood constituents that previously required invasive procedures.
Masimo 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 noninvasive and continuous total
hemoglobin technology will provide faster, easier and safer means for
measuring total hemoglobin and will lead to additional device sales, and risks
related to our assumption that noninvasive total hemoglobin will be available
in the first quarter of 2009, as well as other factors discussed in the "Risk
Factors" section of our quarterly report on Form 10-Q for the quarter ended
June 28, 2008, filed with the Securities and Exchange Commission on August 5,
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 June 28, 2008, whether as a result
of new information, future events or otherwise, except as may be required
under the federal securities laws.
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
09/15/2008
Web site: http://www.masimo.com
(MASI)