Masimo (NASDAQ: MASI) today announced Pathway™, a feature for
the Root® Patient Monitoring and Connectivity Platform. Pathway
provides clinicians with a way to visualize a hospital’s
recommended resuscitation protocol for a newborn’s oxygen
saturation (SpO2) while continuously monitoring SpO2 and pulse rate
(PR) during the first ten minutes after birth. Use of Pathway is
intended to help streamline clinician workflow and improve protocol
adherence during this critical period. Pathway was invented by Dr.
Yacov Rabi, MD, Associate Professor in the Department of Pediatrics
at the Cumming School of Medicine, University of Calgary, Canada,
and licensed to Masimo.
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Root® with Pathway™ (Photo: Business
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The International Liaison Committee on Resuscitation (American
Heart Association) has developed treatment recommendations
outlining time-based SpO2 targets that reflect a healthy newborn’s
oxygenation during the first ten minutes after birth.1 Current
hospital practice relies on manually referencing charts or
clinician recollection for adherence to protocols based on these
recommendations. The ability to display local oxygen saturation
targeting guidelines while still actively monitoring SpO2 and PR
via Pathway’s intuitive interface is intended to help clinicians
more easily adhere to their institution’s resuscitation protocols.
While Pathway is active, Root displays SpO2 values alongside a
visualization of the hospital-defined SpO2 targets over time. To
help clinicians track time since birth, Pathway displays an easily
adjustable timer bar so that clinicians no longer need to mentally
track the difference between the time of birth and the start of
monitoring. Pathway can also provide hospitals with the ability to
monitor and capture data involving adherence to their chosen
newborn resuscitation protocols.
Dr. Rabi commented, “We created Pathway to simplify decision
making during newborn resuscitation. I’m especially excited by the
ability to review oxygen-saturation-targeting performance
post-resuscitation as a means of supporting quality improvement and
quality assurance initiatives at each institution.”
Pathway’s visualization on Root works in tandem with continuous
SpO2 monitoring powered by Masimo SET® Measure-through Motion and
Low Perfusion™ technology, which has been shown in over 100
independent and objective studies to outperform other pulse
oximetry technologies.2 Crucially for newborn health, SET® has been
shown to help clinicians reduce severe retinopathy of prematurity
in neonates3 and in multiple studies, including the largest
critical congenital heart disease (CCHD) study to date, to improve
CCHD screening in newborns.4-5
Masimo Root is a powerful, versatile, and ever more expandable
monitoring and connectivity hub designed for use across the
continuum of care. Root integrates an array of technologies,
devices, and systems to provide multimodal monitoring and
automation solutions. Root’s plug-and-play expansion capabilities
allow clinicians to simultaneously monitor with core Masimo
technologies such as SET® pulse oximetry and rainbow® Pulse
CO-Oximetry while incorporating additional modalities such as
SedLine® brain function monitoring, O3® regional oximetry,
NomoLine® capnography, and more – all via an easy-to-interpret,
customizable display that can also be set to Vital Signs Check mode
and now Pathway mode. Using Root in combination with Patient
SafetyNet™ or Iris Gateway™, monitoring data 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 newborns and infants in mind. These patients were
never an afterthought, and we continue to seek new ways to help
clinicians provide them with the best care possible. One such
result is Pathway, which visualizes the reliable, accurate data
harnessed by SET® in an innovative and intuitive new manner. We
hope that Pathway will help clinicians more efficiently and easily
keep track of a newborn’s status during the critical first minutes
after birth.”
@MasimoInnovates | #Masimo
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.2 Masimo SET® has also been shown to
help clinicians reduce severe retinopathy of prematurity in
neonates,3 improve CCHD screening in newborns,4 and, when used for
continuous monitoring with Masimo Patient SafetyNet™ in
post-surgical wards, reduce rapid response team activations, ICU
transfers, and costs.6-8 Masimo SET® is estimated to be used on
more than 100 million patients in leading hospitals and other
healthcare settings around the world,9 and is the primary pulse
oximetry at 9 of the top 10 hospitals listed in the 2019-20 U.S.
News and World Report Best Hospitals Honor Roll.10 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
-
https://www.ahajournals.org/doi/full/10.1161/CIR.0000000000000267.
- 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.
- 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.
- Zhao et al. Pulse oximetry with clinical assessment to screen
for congenital heart disease in neonates in China: a prospective
study. Lancet. 2014 Aug 30;384(9945):747-54.
- 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 Pathway™, SET ®,
and Root ®. 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 Pathway™, SET ®, and Root,
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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Masimo Evan Lamb 949-396-3376 elamb@masimo.com
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