Masimo Announces FDA Clearance of Neonatal Indication for O3® Regional Oximetry
June 10 2019 - 8:00AM
Business Wire
Masimo (NASDAQ: MASI) announced today that O3® Regional
Oximetry has received FDA clearance for use on neonatal and infant
patients (<10 kg). O3 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 this
expansion of the O3 platform, the benefits of monitoring with O3
are now available to patients of all ages, from neonates to
adults.
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Masimo Root® with O3® Regional Oximetry
(Photo: Business Wire)
O3, which uses near-infrared spectroscopy (NIRS) to monitor the
regional hemoglobin oxygen saturation of blood (rSO2) on both sides
of the brain, may be particularly helpful in providing insight into
neonatal patient status because neonatal pathology is often
brain-related.1 In neonates, O3 provides reliable measurement with
a 3% ARMS* trending accuracy specification.
O3 sensors are available in three sizes, for adult (≥40 kg),
pediatric (≥5 kg and <40 kg) and now infant and neonatal (<10
kg) patients. With its smaller size and flexible design, the
neonatal sensor is designed to fit easily and comfortably on the
delicate foreheads of tiny patients.
O3 is available as a Masimo Open Connect® (MOC-9®) module for
the Root® Patient Monitoring and Connectivity Platform. Root is a
powerful, expandable hub that integrates an array of technologies,
devices, and systems to provide multimodal monitoring and
connectivity solutions. Root’s plug-and-play expansion capabilities
allow clinicians to simultaneously monitor with O3 and other
measurements, such as SET® Measure-through Motion and Low
Perfusion™ pulse oximetry, providing clinicians with expanded
visibility of neonatal oxygenation status. Additional modalities
available on Root include advanced rainbow® noninvasive
measurements such as total hemoglobin (SpHb®), SedLine® brain
function monitoring (available for adult patients), NomoLine®
capnography, and more – all via an easy-to-interpret, customizable
display. Using Root in combination with Masimo Patient SafetyNet™
or Iris Gateway™, monitoring data from O3 can be automatically
charted in electronic medical records (EMRs).
Joe Kiani, Founder and CEO of Masimo, said, “From our inception,
we have been committed to improving outcomes for the youngest and
most fragile patients. Our foundational SET® pulse oximetry was
designed with neonates and infants in mind. These patients were not
an afterthought. This focus has paid off for these young patients:
SET® pulse oximetry has helped clinicians reduce the incidence of
severe retinopathy of prematurity (ROP) in neonates2 and improve
critical congenital heart disease (CCHD) screening in newborns.3 O3
Regional Oximetry, with its ability to help clinicians accurately
track cerebral oxygen saturation, will hopefully have a similar
impact. We are happy to be able to bring O3’s advanced capabilities
and accuracy to the neonatal patient population.”
@MasimoInnovates | #Masimo
*ARMS accuracy is a statistical calculation of the difference
between device measurements and reference measurements.
Approximately two-thirds of the device measurements fell within ±
ARMS of the reference measurements in a controlled study.
About Masimo
Masimo (NASDAQ: MASI) is a global medical technology company
that develops and produces a wide array of industry-leading
monitoring technologies, including innovative measurements,
sensors, patient monitors, and automation and connectivity
solutions. Our mission is to improve patient outcomes and reduce
the cost of care. Masimo SET® Measure-through Motion and Low
Perfusion™ pulse oximetry, introduced in 1995, has been shown in
over 100 independent and objective studies to outperform other
pulse oximetry technologies.4 Masimo SET® has also been shown to
help clinicians reduce severe retinopathy of prematurity in
neonates,2 improve CCHD screening in newborns,3 and, when used for
continuous monitoring with Masimo Patient SafetyNet™ in
post-surgical wards, reduce rapid response team activations, ICU
transfers, and costs.5-7 Masimo SET® is estimated to be used on
more than 100 million patients in leading hospitals and other
healthcare settings around the world,8 and is the primary pulse
oximetry at 9 of the top 10 hospitals listed in the 2018-19 U.S.
News and World Report Best Hospitals Honor Roll.9 Masimo continues
to refine SET® and in 2018, announced that SpO2 accuracy on RD SET™
sensors during conditions of motion has been significantly
improved, providing clinicians with even greater confidence that
the SpO2 values they rely on accurately reflect a patient’s
physiological status. 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®),
Pleth Variability Index (PVi®), RPVi™ (rainbow® PVi), and Oxygen
Reserve Index (ORi™). In 2013, Masimo introduced the Root® Patient
Monitoring and Connectivity Platform, built from the ground up to
be as flexible and expandable as possible to facilitate the
addition of other Masimo and third-party monitoring technologies;
key Masimo additions include Next Generation SedLine® Brain
Function Monitoring, O3® Regional Oximetry, and ISA™ Capnography
with NomoLine® sampling lines. Masimo’s family of continuous and
spot-check monitoring Pulse CO-Oximeters® includes devices designed
for use in a variety of clinical and non-clinical scenarios,
including tetherless, wearable technology, such as Radius-7® and
Radius™ PPG, portable devices like Rad-67™, fingertip pulse
oximeters like MightySat® Rx, and devices available for use both in
the hospital and at home, such as Rad-97™. Masimo hospital
automation and connectivity solutions are centered around the Iris®
platform, and include Iris Gateway™, Patient SafetyNet, Replica™,
Halo ION™, UniView™, and Doctella™. Additional information about
Masimo and its products may be found at www.masimo.com. Published
clinical studies on Masimo products can be found at
www.masimo.com/evidence/featured-studies/feature/.
ORi and RPVi have not received FDA 510(k) clearance and are not
available for sale in the United States. The use of the trademark
Patient SafetyNet is under license from University HealthSystem
Consortium.
References
- Dix et al. Monitoring Cerebral
Oxygenation in Neonates: An Update. Frontiers in Pediatrics.
2017.
- 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.
- 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;Jan 8;338.
- Published clinical studies on pulse
oximetry and the benefits of Masimo SET® can be found on our
website at http://www.masimo.com. Comparative studies include
independent and objective studies which are comprised of abstracts
presented at scientific meetings and peer-reviewed journal
articles.
- 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.
- Taenzer A et al. Postoperative
Monitoring – The Dartmouth Experience. Anesthesia Patient Safety
Foundation Newsletter. Spring-Summer 2012.
- 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.
- Estimate: Masimo data on file.
-
http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.
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®. 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, contribute to positive clinical
outcomes and patient safety; risks related to our belief that
Masimo noninvasive medical breakthroughs provide cost-effective
solutions and unique advantages; 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.
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MasimoEvan Lamb949-396-3376elamb@masimo.com
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