DUBAI, United Arab Emirates-Thursday 28 June 2018 [ AETOS Wire ]
(BUSINESS WIRE) -- 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.
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.
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1.Hoffman JL et al. The incidence of congenital heart disease. J Am Coll Cardiol. 2002;39(12):1890-1900.
2.2011 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.
3.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.
4.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.
5.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.
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.
1.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.
2.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.
3.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.
4.Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5.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.
6.Estimate: Masimo data on file.
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.
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