IRVINE, Calif.--(BUSINESS WIRE)--May 30, 2017--
Masimo
(NASDAQ:MASI) announced today FDA 510(k) clearance for the pediatric
indication for O3™ regional oximetry with the O3 pediatric sensor.
Regional oximetry, also referred to as tissue or cerebral oximetry, may
help clinicians monitor cerebral oxygenation in situations in which
peripheral pulse oximetry alone may not be fully indicative of the
oxygen in the brain. With the clearance of the O3 pediatric sensor, O3
regional oximetry monitoring, which was already available for adult
patients in the United States, is now also available for pediatric
patients weighing more than 5 kg (11 lbs) and less than 40 kg (88 lbs).
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Masimo O3™ Regional Oximetry Pediatric (top) and Adult (bottom) Sensors (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 are important
tools in helping patients avoid postoperative morbidity and adverse
outcomes.1
“O3 regional oximetry provides access to valuable data about cerebral
oxygen saturation,” said Joe Kiani, Founder and CEO of Masimo. “With
adult and pediatric trend accuracy of 3% and absolute accuracy of 4% and
5% on adults and pediatrics respectively,2 without
controlling CO2, Masimo O3 should help clinicians build a
better picture of brain oxygenation – and hopefully better outcomes for
all of their patients, including pediatrics as young as three-months old.2”
In addition, 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.
@MasimoInnovates |
#Masimo
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References
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1.
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Booth, Dukatz, Ausman, and Wider. “Cerebral and somatic venous
oximetry in adults and infants.” Surg. Neurol Int. 2010; 1:
75.
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2.
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Masimo data on file.
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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® has also been
shown to help clinicians reduce severe retinopathy of prematurity in
neonates,1 improve CCHD screening in newborns,2
and, when used for continuous monitoring with Masimo Patient SafetyNet™*
in post-surgical wards, reduce rapid response activations and costs.3,4,5
Masimo SET® is estimated to be used on more than 100 million
patients in leading hospitals and other healthcare settings around the
world,6 including 16 of the top 20 hospitals listed in the
2016-17 U.S. News and World Report Best Hospitals Honor Roll.7
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, enabling other companies to augment
Root with new features and measurement capabilities. Masimo is also
taking an active leadership role in mHealth with products such as the
Radius-7™ wearable patient monitor, iSpO2® pulse
oximeter for smartphones, and the MightySat™ fingertip pulse oximeter.
Additional information about Masimo and its products may be found at www.masimo.com.
Published clinical studies on Masimo products can be found at http://www.masimo.com/cpub/clinical-evidence.htm.
*The use of the trademark Patient SafetyNet is under license from
University HealthSystem Consortium.
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References
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1.
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Castillo A et al. Prevention of Retinopathy of Prematurity in
Preterm Infants through Changes in Clinical Practice and SpO2
Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
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2.
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de-Wahl Granelli A et al. Impact of pulse oximetry screening on
the detection of duct dependent congenital heart disease: a
Swedish prospective screening study in 39,821 newborns. BMJ.
2009;338.
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3.
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Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue
Events and Intensive Care Unit Transfers: A Before-And-After
Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
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4.
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Taenzer AH et al. Postoperative Monitoring – The Dartmouth
Experience. Anesthesia Patient Safety Foundation Newsletter.
Spring-Summer 2012.
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5.
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McGrath SP et al. Surveillance Monitoring Management for General
Care Units: Strategy, Design, and Implementation. The Joint
Commission Journal on Quality and Patient Safety. 2016
Jul;42(7):293-302.
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6.
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Estimate: Masimo data on file.
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7.
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http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.
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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; 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/20170530005353/en/
Source: Masimo
Masimo
Evan Lamb, 949-396-3376
elamb@masimo.com