DUBAI, United Arab Emirates--(BUSINESS WIRE)--Jun. 26, 2018--
Masimo (NASDAQ:
MASI) announced today that the United Arab Emirates (UAE) Ministry of
Health & Prevention (MOHAP) is adopting a national screening protocol
for critical congenital heart disease (CCHD) for all newborns. As part
of the program launch, the MOHAP is equipping 9 hospitals across 5
emirates, serving 50% of the UAE population, with Masimo Rad-97™ Pulse
CO-Oximeters® with Eve™ CCHD Newborn Screening Application.
Newborns delivered at these hospitals will now be screened for CCHD
using Eve – the first large-scale installation of Eve on Rad-97, which
received CE marking earlier this year.
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Masimo Rad-97™ with Eve™ (Photo: Business Wire)
CCHD affects approximately 2.5 to 3 newborns per 1000 live births1
and requires intervention soon after birth to prevent significant
morbidity or mortality; later detection in infants also increases the
risk of brain damage.2 In a study of 39,821 infants, CCHD
screening sensitivity increased from 63% with physical exam alone to 83%
with physical exam and Masimo SET® pulse oximetry.3
In a study of 122,738 infants – the largest CCHD screening study to date
– CCHD screening sensitivity increased from 77% to 93% with the combined
use of Masimo SET® and clinical assessment.4
Eve, also available on the Radical-7® Pulse CO-Oximeter,
combines the power of Masimo SET® Measure-through Motion and
Low Perfusion™ pulse oximetry with an automated pre- to post-ductal
synchronization algorithm designed to reduce calculation errors. In
addition, Eve simplifies the CCHD screening process by providing visual
instructions, animations, and a detailed, easy-to-interpret display of
screening results. The ability to label results with unique patient
identifiers for both mother and newborn facilitates intuitive session
management and seamless electronic charting. Eve also allows clinicians
to incorporate perfusion index into screening, which has been shown to
increase sensitivity to the detection of CCHD in infants with
pathologically low perfusion.5
Masimo worked closely with the UAE to implement the MOHAP program,
including onsite training for doctors, nurses, and midwives at each
hospital. H.E. Dr. Yousif Al Serkal, Assistant Undersecretary for the
Hospitals Sector, emphasized the Ministry’s strategy of “providing
comprehensive and innovative health services in accordance with the
highest standards of excellence, professionalism, and leadership in the
health sector. The goal of the ‘Newborn Critical Congenital Heart
Screening Program’ is to ensure that all UAE newborns are screened, and
all affected infants receive appropriate confirmatory testing,
counseling, and treatment to prevent complications and reduce
mortality.” He noted that the program has a comprehensive database and
e-system for the registration of all screening test results, as well as
helping to control quality and track performance through periodic
reporting. Dr. Kalthoom Al Balooshi, Director of the Hospitals
Department, explained that “the screening initiative will be implemented
in nine main hospitals, which includes screening with pulse oximetry, a
CCHD screening database, integrated EMR solutions, and awareness
programs for physicians, nurses, and parents.”
Jon Coleman, President of Worldwide Sales, Professional Services, and
Medical Affairs for Masimo, said, “We are honored that the UAE chose
Masimo to help implement this vital newborn screening process for their
citizens. Masimo SET® performance and accuracy have helped to
usher in reliable and cost-effective CCHD screening, as shown in the
multiple studies concluding that SET® pulse oximetry,
combined with clinical assessment, significantly improved CCHD screening
sensitivity. We believe that Masimo SET® pulse oximetry and
the Eve CCHD Screening App make for a compelling combination, and hope
that more institutions and governments around the world will recognize
the importance of helping their youngest patients get a great start in
life.”
Rad-97 offers Masimo noninvasive and continuous monitoring, through
Measure-through Motion and Low Perfusion SET® pulse oximetry
and upgradeable rainbow® technology, in a compact, standalone
monitor that incorporates advanced customizability, connectivity, and
device integration capabilities. In addition to Eve, Rad-97 is also
available in configurations with integrated noninvasive blood pressure
measurement and integrated NomoLine™ capnography.
@MasimoInnovates |
#Masimo
References
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1.
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Hoffman JL et al. The incidence of congenital heart disease. J
Am Coll Cardiol. 2002;39(12):1890-1900.
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2.
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2011 Legislative Report; State of Maryland, Department of Health and
Mental Hygiene, State Advisory Council on Hereditary and Congenital
Disorders. Recommendations on Implementation of Screening for
Critical Congenital Heart Disease in Newborns. Page 7.
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3.
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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.
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4.
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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.
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5.
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de-Wahl Ganelli et al. Noninvasive Peripheral Perfusion Index as a
Possible Tool for Screening for Critical Left Heart Obstruction. Acta
Paediatr. 2007 Oct;96(10):1455-1459.
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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,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 17 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/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
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1.
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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.
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2.
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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.
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3.
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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.
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4.
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Taenzer AH et al. Postoperative Monitoring – The Dartmouth
Experience. Anesthesia Patient Safety Foundation Newsletter.
Spring-Summer 2012.
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5.
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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.
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6.
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Estimate: Masimo data on file.
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7.
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http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.
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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 Rad-97™, Eve™, and Radical-7®. 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 Rad-97, Eve, and Radical-7,
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/20180626006610/en/
Source: Masimo
Masimo
Evan Lamb
949-396-3376
elamb@masimo.com