Masimo Receives FDA Clearance for New Rainbow(R) Resposable(TM) Sensor System
2009年7月21日 - 9:00PM
PRニュース・ワイアー (英語)
Innovative Combination Reusable-Disposable Sensor System Provides
Cost-Effective & Environmentally Green Pulse CO-Oximetry
Monitoring IRVINE, Calif., July 21 /PRNewswire-FirstCall/ -- Masimo
(NASDAQ:MASI), the inventor of Pulse CO-Oximetry(TM) and
Measure-Through Motion and Low-Perfusion pulse oximetry, today
announced the FDA 510(k) clearance of its new Masimo Rainbow
Resposable(TM) Sensor System, a revolutionary new sensor system
that offers the performance and comfort of a single-use adhesive
disposable sensor with the cost-effectiveness and
environmentally-green advantages of a reusable sensor. The new
sensor system provides continuous and noninvasive measurements of
hemoglobin (SpHb(TM)), oxygen content (SpOC(TM)), PVI(TM) for fluid
responsiveness, and methemoglobin (SpMet ), in addition to oxygen
saturation (SpO2), perfusion index, and pulse rate - at savings of
about 50% compared to the existing single patient use adhesive
Rainbow sensor. (Photo:
http://www.newscom.com/cgi-bin/prnh/20090721/LA49331) The Rainbow
Resposable Sensor System combines the best features of Masimo LNOP
, LNCS , and Rainbow sensors into an innovative two-piece design
that includes a reusable sensor - enabling the portion that
connects to the patient cable to be used on multiple patients -
while the adhesive disposable sensor that attaches directly to the
patient's finger is used on only one patient. This dramatically
minimizes waste, enabling hospitals to reduce their costs safely,
and effectively fulfill their 'green' initiatives. The reusable
portion of the two-piece system provides multi-patient use for
cost-effectiveness, while the flexible cable design maximizes
patient comfort, and enables easy, one-step cleaning. The
snap-in-place connector design allows easy connection and
reconnection to the same patient - and reuse on the next patient.
The single-use disposable portion of system features an adhesive
that keeps emitter and detector positions stable against the skin
to assure the best in Masimo SET and Rainbow SET measurement
performance. The design maximizes fit and comfort for the patient,
while the protective covering minimizes contact with patient to
reduce cross contamination risk. "We have tried the Masimo Rainbow
Resposable System and found that these sensors provided us with all
of the benefits and superior performance of Masimo's continuous and
noninvasive Rainbow measurements, including noninvasive hemoglobin
monitoring, along with the cleanliness and patient comforts of the
standard single patient use sensor at a fraction of the cost and
waste," stated Bertrand Debaene, M.D., Department of Anesthesia at
the University Hospital Center in Poitiers, France. "The Masimo
Rainbow Resposable Sensor System is based on more than ten years of
research and development stemming from the feedback of hundreds of
clinicians who told us what they wanted most in a sensor - less
waste and more value with superior performance," stated Masimo
Founder and CEO, Joe E. Kiani. "We are happy that by combining the
performance and patient comfort of a single-use adhesive sensor
with the cost effectiveness of a reusable sensor, the Masimo
Rainbow Resposable Sensor System also minimizes medical waste and
its impact on the environment." A Capgemini study released earlier
this year showed that a typical 500-bed hospital incorporating
Masimo Rainbow SET Pulse CO-Oximetry into its clinical standards
and care pathways could generate nearly $500,000 in net annual cost
savings and financial gains. With the Masimo Rainbow Resposable
Sensor System, the potential savings to hospitals could increase to
nearly $700,000 annually. 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 ), methemoglobin (SpMet ), 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 includes forward-looking statements as defined
in Section 27A of the Securities Act of 1933 and Section 21E of the
Securities Exchange Act of 1934, in connection with the Private
Securities Litigation Reform Act of 1995. These forward-looking
statements are based on current expectations about future events
affecting us and are subject to risks and uncertainties, all of
which are difficult to predict and many of which are beyond our
control and could cause our actual results to differ materially and
adversely from those expressed in our forward-looking statements as
a result of various risk factors, including, but not limited to:
risks related to our belief that the features, function and design
of the Masimo Rainbow Resposable Sensor System will enable
hospitals to reduce associated waste and costs, as well as other
factors discussed in the "Risk Factors" section of our Quarterly
Report on Form 10-Q for the fiscal quarter year ended April 4,
2009, filed with the Securities and Exchange Commission ("SEC") on
May 6, 2009, which may be obtained for free at the SEC's website at
http://www.sec.gov/. Although we believe that the expectations
reflected in our forward-looking statements are reasonable, we do
not know whether our expectations will prove correct. All
forward-looking statements included in this press release are
expressly qualified in their entirety by the foregoing cautionary
statements. You are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of today's date. 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 fiscal quarter year ended
April 4, 2009, filed with the Securities and Exchange Commission
("SEC") on May 6, 2009, whether as a result of new information,
future events or otherwise, except as may be required under the
applicable 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.
http://www.newscom.com/cgi-bin/prnh/20090721/LA49331 DATASOURCE:
Masimo CONTACT: Dana Banks of Masimo Corporation, +1-949-297-7348
Web Site: http://www.masimo.com/
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