Masimo MightySat Rx, Now Also Indicated for Use at Home, is the First
Fingertip Pulse Oximeter with SET® and the
First to Measure Respiration Rate
IRVINE, Calif.--(BUSINESS WIRE)--Jan. 28, 2019--
Masimo (NASDAQ:
MASI) announced today FDA clearance of the measurement of respiration
rate from the pleth (RRp®) on the MightySat™ Rx spot-check
fingertip pulse oximeter, as well as its indication for use in the home
environment. The addition of RRp to MightySat Rx, which also measures
functional oxygen saturation (SpO2), pulse rate (PR),
perfusion index (Pi), and Pleth Variability Index (PVi®),
makes it a more thorough and versatile spot-check solution.
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Masimo MightySat™ Rx with RRp® (Photo: Business Wire)
Respiration rate, or the number of breaths taken per minute, typically
requires manually counting breaths with a timer and then converting to a
rate per minute, or being fitted with chest leads or straps that can be
inconvenient. With RRp, respiration rate can conveniently be measured
using the same optical sensor that measures SpO2, PR, Pi, and
PVi. RRp is provided only when the respiratory movement-induced signal
is present in the pulsatile waveform and may not be available during
certain conditions, such as very irregular breathing and excessive
movement.
With the introduction of RRp to the U.S., Masimo now offers clinicians
more ways to accurately measure breathing rate than ever, helping to
ensure they have the right tools for each patient scenario. RRp on
MightySat Rx offers a convenient, fast, and portable option, adding to
the portfolio of respiratory solutions from Masimo that includes
continuous, acoustic respiration rate monitoring using RRa®
and capnography-based solutions using NomoLine®.
Alongside RRp, PVi, PR, and Pi, MightySat Rx features the same
Measure-through Motion and Low Perfusion™ SET® pulse oximetry
available in a variety of bedside Masimo and OEM monitors. SET®
has been shown in over 100 independent and objective studies to
outperform other pulse oximetry technologies,1 is estimated
to be used on more than 100 million patients a year,2 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.3
The benefits of SET® are maximized by choosing the
correct sensor type for each use scenario: adhesive sensors for
continuous monitoring, reusable sensors for short-term monitoring, and
MightySat Rx fingertip oximeters for spot-check measurements.
MightySat Rx is small and light, weighing less than 100 grams (with
batteries), but also durable and long-lasting, with an IP23 ingress
rating (protected from water spraying from up to 60 degrees from
vertical) and providing approximately 1,800 spot-checks with each set of
2 AAA batteries. Available in both black and white, MightySat offers a
high-resolution color display, including display of plethysmographic
waveforms, as well as a Bluetooth® wireless interface to the
Masimo Professional Health mobile application to track, trend, and
communicate measurements.
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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. 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,4 improve CCHD screening in newborns,5
and, when used for continuous monitoring with Masimo Patient SafetyNet™
in post-surgical wards, reduce rapid response activations 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,2 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.3 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®), and more
recently, 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/evidence/featured-studies/feature/.
ORi has not received FDA 510(k) clearance and is not available for sale
in the United States. The use of the trademark Patient SafetyNet is
under license from University HealthSystem Consortium.
References
-
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.
-
Estimate: Masimo data on file.
- http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.
-
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 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.
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 MightySat™ Rx and RRp®. 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 MightySat Rx and RRp,
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190128005178/en/
Source: Masimo
Masimo
Evan Lamb
949-396-3376
elamb@masimo.com