Wearable, Wireless Patient Orientation,
Activity, and Respiration Sensor Helps Clinicians Monitor Patient
Position and Respiration Rate
Masimo (NASDAQ: MASI) announced today that Centroid™, a
wearable, wireless patient orientation, activity, and respiration
rate sensor, has received FDA clearance. Centroid helps clinicians
monitor patient position to avoid preventable pressure ulcers, and
can alert clinicians to sudden movements such as fall-like events.
In addition, Centroid detects chest movements to continuously
provide respiration rate, assisting clinicians with additional data
that may inform care decisions.
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Masimo Centroid™ (Photo: Business
Wire)
Centroid pairs with the Root® Patient Monitoring and
Connectivity Platform using Bluetooth® to track a patient’s
posture, orientation, and activity, providing the ability to
monitor patient position and detect changes in position. The data
transmitted by Centroid can be displayed in various formats on
Root, giving clinicians multiple ways to assess adherence to
protocols regarding tissue stress and to tailor care to the
specific needs of each patient.
Pressure sores affect nearly 2.5 million patients per year in
U.S. hospitals alone, and approximately 60,000 of those patients
die as a direct result.1 Centroid is indicated for the orientation
monitoring of patients who may be susceptible to pressure ulcers,
by tracking patient movement and activity using an accelerometer
and gyroscope. Centroid can identify a patient’s position and
orientation to the nearest degree, with alerts based on the
duration in a static position to help clinicians adhere to hospital
patient turn protocols. Centroid also features customizable alarm
zones to help avoid patient positions that could negatively impact
recovery time. Unlike simple time-based rotation protocols,
Centroid uses the cumulative time spent in each position, as well
as existing sore data, to calculate relative risk, displayed on the
Root screen using color-coded markers, helping clinicians identify
the potential severity of tissue stress for each position—and
ultimately, helping to guide clinical decisions about the most
appropriate, least risky positions for each patient.
In addition, because Centroid can identify whether a patient is
lying down, standing, sitting upright, walking, or may have fallen,
it can notify clinicians of a sudden change in position that might
provide early warning of a potential fall, by alerting them when
clinician-defined movement thresholds are crossed. Its respiration
rate performance, validated against manually scored capnogram
respiratory measurements, is accurate to within 3 respirations per
minute (rpm) in the range of 8 to 35 rpm.
The Centroid single-patient-use sensor is ergonomically designed
for application on the chest using flexible, lightweight material
for patient comfort, with a gentle adhesive that supports
continuous use during daily activities. Each battery-operated
sensor is designed to last four days, minimizing the need for
frequent replacement.
Joe Kiani, Founder and CEO of Masimo, said, “We are committed to
using our expertise in signal processing and sensor design to
develop new ways to provide the highest quality, most relevant data
to clinicians in the most intuitive, useful formats, and Centroid,
coupled with Root’s rich high-resolution display, is a great
example of this. We hope that by helping to automate the process of
tracking and making decisions about patient position, we can help
clinicians reduce the frequency and severity of pressure ulcers,
and ultimately improve patient outcomes.”
@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.5-7 Masimo SET® is estimated to be used on
more than 200 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 2019-20 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 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
- Preventing Pressure Ulcers in Hospitals. Agency for Healthcare
Research and Quality.
https://www.ahrq.gov/patient-safety/settings/hospital/resource/pressureulcer/tool/pu1.html.
Accessed 23 Apr 2020.
- 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 SpO 2
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.
- 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 Centroid™ 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 Centroid 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; 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200625005893/en/
Media Contact: Masimo Evan Lamb 949-396-3376
elamb@masimo.com
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