NEUCHATEL, Switzerland--(BUSINESS WIRE)--Sep. 5, 2017--
Masimo (NASDAQ:
MASI) announced today the findings of a recently published study in
which researchers in Maastricht, The Netherlands evaluated the
performance of Masimo iSpO2® Rx in screening
newborns for critical congenital heart disease (CCHD).1 iSpO2
Rx is a smart device-paired pulse oximeter featuring Masimo
Measure-through Motion and Low Perfusion™ pulse oximetry technology.
CCHD affects approximately 2.5 to 3 newborns per 1000 live births2
and requires intervention soon after birth to prevent significant
morbidity or mortality; later detection in infants also increases the
risk of brain damage.3 In the study, Dr. Huizing and
colleagues sought to evaluate the accuracy of iSpO2 Rx
because of increasing trends toward out-of-hospital births and concerns
about the costs of CCHD screening implementation in low-resource
settings. The researchers surmised that a portable, low-cost pulse
oximeter may be more practical in such settings than standalone hospital
devices.
The researchers enrolled 201 infants in the study. CCHD screening was
conducted 12-24 hours after birth by two independent teams, who were
blinded to the other team’s results. Each team took both preductal
(right-hand) and postductal (either foot) SpO2 measurements
to establish whether an infant passed, failed, or needed a repeat
screening. One team measured oxygen saturation using a Masimo Radical-7®
Pulse CO-Oximeter® equipped with disposable Masimo LNCS®
sensors. The other team used a Masimo iSpO2 Rx equipped with
a reusable M-LNCS™ YI sensor, connected to an Apple iPad Mini.
Applying Bland-Altman analysis to the preductal SpO2 values
of the 201 screened infants, with Radical-7 as the reference device, the
researchers calculated a mean bias of -0.08% ± standard deviation of
1.76%, with limits of agreement of -3.52% and 3.36%. For postductal SpO2
values, they calculated a mean bias of -0.11% ± standard deviation of
1.68%, with limits of agreement of -3.41% and 3.18%.
In addition, to evaluate the ability of iSpO2 Rx to measure
low oxygen saturation, the researchers also enrolled a group of 12
infants admitted to the neonatal intensive care unit (NICU) with SpO2
lower than 95%. SpO2 was continuously monitored for 10
minutes, with readings recorded once per minute, and with one foot
connected to the iSpO2 Rx and the other to a Philips
IntelliVue MP70 monitor equipped with Masimo SET® technology.
Using the Philips monitor as the reference device, the researchers
calculated a mean bias of 0.01% ± standard deviation of 1.74%, with
limits of agreement of -3.42% and 3.43%.
The researchers concluded that, “Our data suggest that CCHD screening
with the Masimo iSpO2 Rx is feasible and accurate. The use of
reliable smartphone-paired pulse oximeters may contribute to the
extension of CCHD screening to home births and low resource settings.”
They also noted that, “The iSpO2 Rx demonstrated a high
degree of agreement with the Masimo Radical-7, a hospital-grade pulse
oximeter.”
The device used in this study is iSpO2 Rx. The study did not
use the iSpO2, which is intended as an exercise and wellness
product and is not available for use on neonates. iSpO2 is
not intended for CCHD screening or any other medical use.
iSpO2 Rx does not have 510(k) clearance and is not available
for sale in the United States.
@MasimoInnovates |
#Masimo
References
-
Huizing M, Villamor-Martinez-E, Chavagne I, Vanagt W, Spaanderman M,
and Villamor E. Reliability and Validity of a Smartphone-Paired Pulse
Oximeter for Screening of Critical Congenital Heart Defects in
Newborns. Neonatology. 2017;112:324–329. DOI: 10.1159/000477294.
-
Hoffman JL et al. The incidence of congenital heart disease. J Am
Coll Cardiol. 2002 Jun 19;39(12):1890-1900.
-
2011 Legislative Report; State of Maryland, Department of Health and
Mental Hygience, State Advisory Council on Hereditary and Congenital
Disorders. Recommendations on Implementation of Screening for Critical
Congenital Heart Disease in Newborns. Page 7.
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,1 improve CCHD screening in newborns,2
and, when used for continuous monitoring with Masimo Patient SafetyNet™*
in post-surgical wards, reduce rapid response activations and costs.3,4,5
Masimo SET® is estimated to be used on more than 100 million
patients in leading hospitals and other healthcare settings around the
world,6 and is the primary pulse oximetry at 16 of the top 20
hospitals listed in the 2017-18 U.S. News and World Report Best
Hospitals Honor Roll.7 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/cpub/clinical-evidence.htm.
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
-
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;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 AH 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 Radical-7® Pulse CO-Oximeter®
and iSpO2® Rx. 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 Radical-7 Pulse CO-Oximeter and iSpO2 Rx,
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: http://www.businesswire.com/news/home/20170904005059/en/
Source: Masimo
Masimo
Evan Lamb, 949-396-3376
elamb@masimo.com