NEUCHATEL, Switzerland--(BUSINESS WIRE)--Aug. 4, 2016--
Masimo
(NASDAQ: MASI) announced today the CE marking for the pediatric
indication for O3™ regional oximetry with the O3 pediatric sensor.
Regional oximetry, also referred to as tissue or cerebral oximetry,
helps clinicians monitor cerebral oxygenation.
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Masimo Root with SedLine and O3 with Pediatric Sensor (Photo: Business Wire)
O3 regional oximetry uses near-infrared spectroscopy (NIRS) to
continuously monitor absolute and trended regional tissue oxygen
saturation (rSO2) in the cerebral region. Early detection and
correction of imbalances in oxygen delivery to the brain and vital
organs are important tools in helping patients avoid postoperative
morbidity and adverse outcomes.1 With the release of the O3
pediatric sensor, O3 regional oximetry monitoring of rSO2 is
now available to pediatric patients weighing less than 40 kg (88 lbs).
“O3 regional oximetry provides access to valuable data about cerebral
oxygen saturation, and studies have shown that the risks of cerebral
desaturations include neurological injury2,3, increased
length of hospital stays3, increased time on mechanical
ventilation4, and other adverse outcomes5,” said
Joe Kiani, Founder and CEO of Masimo. “With adult trend accuracy of 3%
and absolute accuracy of 4% without controlling CO2, and
trend accuracy of 3% in pediatric patients6, Masimo O3 should
help clinicians build a better picture of brain oxygenation – and
hopefully better outcomes for all of their patients, including pediatric
ones.”
Masimo O3 regional oximetry and SedLine® brain function
monitoring are both available on a single platform, Masimo Root®
– opening up a path to better understanding of the brain.
O3 regional oximetry for use with adults weighing 40 kg (88 lbs) or
greater has received FDA 510(k) clearance. O3 regional oximetry for use
with pediatric patients weighing less than 40 kg (88 lbs) has not
received FDA 510(k) clearance; the O3 pediatric sensor is not currently
for sale in the United States.
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| #Masimo
References
-
Booth, Dukatz, Ausman, and Wider. “Cerebral and somatic venous
oximetry in adults and infants.” Surg. Neurol Int. 2010; 1: 75.
-
Colak Z, Borojevic M, Bogovic A, Ivancan V, Biocina B, Majeric-Kogler
V. Influence of intraoperative cerebral oximetry monitoring on
neurocognitive function after coronary artery bypass surgery: a
randomized, prospective study. European journal of cardio-thoracic
surgery : official journal of the European Association for
Cardio-thoracic Surgery. 2015 Mar;47(3):447-54.
-
Slater JP, Guarino T, Stack J, et al. Cerebral Oxygen Desaturation
Predicts Cognitive decline and longer hospital stay after cardiac
surgery. Ann Thorac Surg 2009;87:36-45.
-
Goldman S, Sutter F, Ferdinand F, Trace C. Optimizing intraoperative
cerebral oxygen delivery using noninvasive cerebral oximetry decreases
the incidence of stroke for cardiac surgical patients. The heart
surgery forum. 2004;7(5):E376-381.
-
Deschamps A, Lambert J, Couture P, et al. Reversal of decreases in
cerebral saturation in high-risk cardiac surgery. Journal of
cardiothoracic and vascular anesthesia. 2013;27(6):1260-1266.
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Masimo data on file.
About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive
monitoring technologies. Our mission is to improve patient outcomes and
reduce the cost of care by taking noninvasive monitoring to new sites
and applications. In 1995, the company debuted Masimo SET®
Measure-through Motion and Low Perfusion™ pulse oximetry, which has been
shown in multiple studies to significantly reduce false alarms and
accurately monitor for true alarms. Masimo SET® is estimated
to be used on more than 100 million patients in leading hospitals and
other healthcare settings around the world. In 2005, Masimo introduced
rainbow® Pulse CO-Oximetry technology, allowing noninvasive
and continuous monitoring of blood constituents that previously could
only be measured invasively, including total hemoglobin (SpHb®),
oxygen content (SpOC™), carboxyhemoglobin (SpCO®),
methemoglobin (SpMet®), and more recently, Pleth Variability
Index (PVI®) and Oxygen Reserve Index (ORI™), in addition to
SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo
introduced Root®, an intuitive patient monitoring and
connectivity platform with the Masimo Open Connect™ (MOC-9™) interface.
Masimo is also taking an active leadership role in mHealth with products
such as the Radius-7™ wearable patient monitor and the MightySat™
fingertip pulse oximeter. Additional information about Masimo and its
products may be found at www.masimo.com.
All published clinical studies on Masimo products can be found at http://www.masimo.com/cpub/clinical-evidence.htm.
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 include, among others, statements regarding the potential
effectiveness of Masimo O3™ Regional Oximetry. 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
assumptions regarding the repeatability of clinical results; risks
related to our belief that Masimo's unique noninvasive measurement
technologies, including Masimo O3™ Regional Oximetry, contribute to
positive clinical outcomes and patient safety; risks related to our
belief that Masimo noninvasive medical breakthroughs provide
cost-effective solutions with comparable accuracy and unique advantages,
including: immediate and continuous results that enable earlier
treatment without causing invasive trauma in all patients and in every
clinical situation; as well as other factors discussed in the "Risk
Factors" section of our most recent reports filed with the Securities
and Exchange Commission ("SEC"), which may be obtained for free at the
SEC's website at 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 statements or the "Risk Factors" contained in our most
recent reports filed with the SEC, whether as a result of new
information, future events or otherwise, except as may be required under
the applicable securities laws.
View source version on businesswire.com: http://www.businesswire.com/news/home/20160804005515/en/
Source: Masimo
Masimo
Irene Paigah, 858-859-7001
irenep@masimo.com