Masimo (NASDAQ: MASI) today announced that O3® Regional Oximetry
has received FDA clearance for expanded use in monitoring somatic
tissue oxygenation saturation in all patient populations and
monitoring relative changes in hemoglobin, oxyhemoglobin, and
deoxyhemoglobin in adult brains. With this FDA clearance, O3 is now
indicated for use in both cerebral and somatic applications, both
in the U.S. and in CE mark countries, for all patient
populations.
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Masimo Root® with O3® Regional Oximetry
(Photo: Business Wire)
O3 Regional Oximetry provides regional or tissue hemoglobin
oxygen saturation with a trending specification of 3% ARMS*
(cerebral and somatic, all ages) and absolute accuracy
specifications of 4% ARMS (cerebral, adults) and 5% ARMS (cerebral,
pediatric patients) through the use of O3 multi-wavelength sensors
and O3 Regional Oximetry near-infrared spectroscopy (NIRS)
technology. Unlike peripheral pulse oximetry, which reflects the
body’s general arterial blood oxygenation, O3 provides information
about the local tissue’s hemoglobin oxygen saturation, both in
cerebral and somatic applications. This information provides
additional insight that may help inform clinicians of changes in
cerebral or somatic tissue oxygen levels. Monitoring renal tissue
oxygenation in neonates has been found to help provide early
warning of renal dysfunction.1 Monitoring both brain and somatic
tissue oxygenation simultaneously may further improve clinicians’
ability to provide rapid and accurate care.2
André Denault, MD, PhD, Department of Anesthesiology, Critical
Care Program at the Montreal Heart Institute and Central Hospital
of the University of Montreal, said, “There is a growing interest
in the use of somatic NIRS owing to the association of cerebral and
somatic desaturation with unfavorable outcomes in shock states. As
an addition to O3 cerebral oximetry, the somatic component could
serve as an earlier warning of impaired tissue perfusion. Somatic
NIRS has been validated as a monitor of peripheral perfusion and
shows an excellent correlation with peripheral perfusion compared
with radionuclide plethysmography. As previously reported,3
cerebral and somatic NIRS combined with bedside whole-body
ultrasound can help in early detection of different types of shock
to formulate proper therapeutic strategies.”
Along with FDA clearance for somatic monitoring, the O3
measurements ΔcHb, ΔO2Hb, and ΔHHb are cleared for the monitoring
of relative changes in oxygenated hemoglobin (ΔO2Hb), deoxygenated
hemoglobin (ΔHHb), and total hemoglobin (ΔcHb) in adult brains.
With the expanded indications for ΔcHb, ΔO2Hb, and ΔHHb, clinicians
gain information that may provide insight into the dynamic
relationship between oxygen and hemoglobin in the brain that brain
oxygenation saturation (rSO2) alone may not provide.
Dr. Aamer Ahmed, FRA FESC FACC, Consultant Cardiovascular
Anesthesiologist at University Hospitals of Leicester, UK, said,
“When using regional oximetry to monitor the brain, rSO2 helps
track the oxygenation state of the brain, but understanding the
dynamic variations in rSO2 is even more valuable. Changes in rSO2
may be a function of a change in hemoglobin or perfusion, or may
result from an oxygen desaturation event. In my practice, I use
Masimo O3 ΔcHb, ΔO2Hb, and ΔHHb to gain insight into the relative
changes in hemoglobin and perfusion in the brain to help enable
earlier detection and intervention during adverse changes to
cerebral blood flow.”
O3 seamlessly integrates with Masimo SedLine® brain function
monitoring on the Root® Patient Monitoring and Connectivity
Platform, 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,
SedLine, and other measurements, such as SET® Measure-through
Motion and Low Perfusion™ pulse oximetry, providing clinicians with
expanded visibility of oxygenation status. Additional modalities
available on Root include advanced rainbow® noninvasive
measurements such as total hemoglobin (SpHb®) and PVi® (an
indicator of fluid responsiveness), NomoLine® capnography, and more
– all via an easy-to-interpret, customizable display. Using Root in
combination with Masimo Iris Gateway®, monitoring data from O3 can
be automatically charted in electronic medical records (EMRs).
Joe Kiani, Founder and CEO of Masimo, said, “O3’s expanded
indication as a monitor of the oxygenation and deoxygenation
components of cerebral tissue, along with the oxygen saturation of
somatic tissue, represents an important milestone in helping
clinicians and researchers shed additional light on how the body
utilizes oxygen and in uncovering organ hypoxemia.”
@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,5 improve CCHD screening in newborns,6 and, when used for
continuous monitoring with Masimo Patient SafetyNet™ in
post-surgical wards, reduce rapid response team activations, ICU
transfers, and costs.7-10 Masimo SET® is estimated to be used on
more than 200 million patients in leading hospitals and other
healthcare settings around the world,11 and is the primary pulse
oximetry at 9 of the top 10 hospitals according to the 2020-21 U.S.
News and World Report Best Hospitals Honor Roll.12 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
Masimo Hospital Automation™ platform, and include Iris Gateway®,
Patient SafetyNet, Replica™, Halo ION™, UniView™, UniView: 60™, and
Masimo SafetyNet™. 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
- Hoffman et al. Perioperative perfusion assessed by somatic NIRS
predicts postoperative renal dysfunction. Anesthesiology 2005; 103:
A1327*.
- Lecluyse et al. Desaturation in the Intensive Care Unit:
Preliminary Experience and Review. J Cardiothoracic Vascular
Anesth. (2017) 1805-1809.
- Denault A et al. A Practical Approach to Cerebro-Somatic
Near-Infrared Spectroscopy and Whole-Body Ultrasound. J Cardio Vasc
Anesth. 2019;03.039. DOI:
https://doi.org/10.1053/j.jvca.2019.03.039
- 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.
- Taenzer A 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 S 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.
- McGrath S et al. Inpatient Respiratory Arrest Associated With
Sedative and Analgesic Medications: Impact of Continuous Monitoring
on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14
Mar. DOI: 10.1097/PTS.0000000000000696.
- 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; risks related to COVID-19; 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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