DUBAI, United Arab Emirates – ( BUSINESS WIRE ) – Masimo (NASDAQ: MASI) today announced that the United Arab Emirates (UAE) Ministry of Health and Prevention (MOHAP) is launching a nationwide screening Protocol for Congenital Heart Disease (CCHD) for all newborns. As part of the launch of the program which equips MOHAP nine clinics in five Emirates, which serve 50% of the population, with Masimo Rad-97 ™ pulse CO-oximeters ® with the Eve ™ CCHD Newborn Screening Application. Newborns born in these clinics are now being tested for CCHD with Eve. This is the first large-scale installation of Eve on Rad-97, which received the CE mark this year.
CCHD affects approximately 2.5 to 3 newborns per 1,000 live births 1and requires early postpartum medical intervention to prevent high morbidity and mortality rates. Later detection in infants also increases the risk of brain damage. 2 In a study of 39,821 infants, detection of CCHD improved from 63% in a purely physical examination to 83% in a physical examination in combination with Masimo SET ® pulse oximetry. 3 In a study of 122,738 infants – the largest CCHD screening study to date – detection of CCHD improved from 77% to 93% through the combined use of Masimo SET ® and medical examination. 4
Eve is also on the Radical-7 ® available pulse-CO-oximeter and combines the power of the Masimo SET ® Measure-through-motion and low-perfusion pulse oximetry ™ with an automated pre-dectal and post-ducal synchronization algorithm designed to minimize computational errors. In addition, Eve simplifies the CCHD screening process by providing visual instructions, animations, and detailed, easy-to-interpret display of test results. The ability to associate results with a unique patient ID of mother and newborn enables intuitive session management and seamless electronic graphics creation. Eve also allows physicians to include the perfusion index5
Masimo has worked closely with the UAE to implement the MOHAP program – including on-site training for doctors, nurses, nurses and midwives in every hospital. HE Dr. Yousif Al Serkal, Deputy Undersecretary for the Hospital Sector, emphasized the Ministry’s strategy of delivering “comprehensive and innovative health services to the highest standards of excellence, professionalism and leadership in each sector. The aim of the “Newborn Critical Congenital Heart Screening Program” is to ensure that all newborns in the UAE are screened and that all affected infants undergo appropriate confirmatory tests. He received advice and treatment to prevent complications and reduce mortality. “He noted that the program has a comprehensive database and e-system for registering all test test results, as well as for quality control and tracking performance through regular reporting , Dr. Kalthoom Al Balooshi, Director of the Hospital Department, said: “The research initiative will be implemented in nine main hospitals. It includes pulse oximetry, a CCHD screening database, integrated EMR solutions and awareness programs for physicians, nurses and sisters and parents. ” He noted that the program has a comprehensive database and e-system for registering all test test results, as well as for quality control and tracking performance through regular reporting. Dr. Kalthoom Al Balooshi, Director of the Hospital Department, said: “The research initiative will be implemented in nine main hospitals. It includes pulse oximetry, a CCHD screening database, integrated EMR solutions and awareness programs for physicians, nurses and sisters and parents. ” He noted that the program has a comprehensive database and e-system for registering all test test results, as well as for quality control and tracking performance through regular reporting. Dr. Kalthoom Al Balooshi, Director of the Hospital Department, said: “The research initiative will be implemented in nine main hospitals. It includes pulse oximetry, a CCHD screening database, integrated EMR solutions and awareness programs for physicians, nurses and sisters and parents. ” the program has a comprehensive database and e-system for registering all test test results, as well as quality control and tracking of performance through regular reporting. Dr. Kalthoom Al Balooshi, Director of the Hospital Department, said: “The research initiative will be implemented in nine main hospitals. It includes pulse oximetry, a CCHD screening database, integrated EMR solutions and awareness programs for physicians, nurses and sisters and parents. ” the program has a comprehensive database and e-system for registering all test test results, as well as quality control and tracking of performance through regular reporting. Dr. Kalthoom Al Balooshi, Director of the Hospital Department, said: “The research initiative will be implemented in nine main hospitals. It includes pulse oximetry, a CCHD screening database, integrated EMR solutions and awareness programs for physicians, nurses and sisters and parents. “
Jon Coleman, President of Worldwide Sales, Professional Services, and Masai’s Medical Affairs, said: “It is an honor for us that the UAE has chosen Masimo for the implementation of this vital public inquiry process. The power and precision of Masimo SET ® allowed us to initiate reliable, cost-effective CCHD investigations. This has been shown in several studies that conclude that the SET ® improves -Pulsoximetrie in conjunction with clinical assessments detection of CCHD significantly. We believe that the Masimo SET ®Pulse oximetry and the Eve CCHD Screening App make an attractive combination, and hope that more institutions and governments around the world realize the importance of helping their youngest patients get off to a good start. “
Rad-97 provides non-invasive, continuous monitoring of Masimo about Measure-through Motion and Low Perfusion-SET ® -Pulsoximetrie and upgradable rainbow ® technology in a compact, stand-alone monitor, the advanced adaptability, connectivity and capacity for integrating Devices offers. In addition to EVE, Rad-97 is also available in configurations with integrated noninvasive blood pressure measurement and integrated NomoLine ™ capnometry.
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literature
1. |
Hoffman JL et al. The incidence of congenital heart disease. J Coll Coll Cardiol. 1890-1900: 39 (12); of 2002. |
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Second | Legislative Report 2011; State of Maryland, Department of Health and Mental Health, Advisory Committee on Hereditary and Congenital Diseases. Recommendations for the use of screening for critical congenital heart defects in newborns. Page 7. | |||||
Third |
de-election Granelli A et al. Impact of pulse oximetry screening on the detection of duct congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ . 2009; 8th Jan; 338th |
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4th |
Zhao et al. Pulse oximetry with congenital heart disease clinical assessment of neonates in China: a prospective study. Lancet . 2014 Aug 30; 384 (9945): 747-54. |
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5th |
de-election Ganelli et al. Noninvasive Peripheral Perfusion Index as a Possible Tool for Screening 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 surveillance technologies. Our mission is to improve patient outcomes and reduce nursing costs. In 1995, the company has for the first time the technologies Masimo SET ®presented Measure-through Motion and Low Perfusion pulse oximetry ™ for. Several studies have shown that this can significantly reduce the number of false alarms and allow accurate monitoring with the correct triggering of alarms. Masimo SET ® has also been proven to help clinicians reduce severe preterm neonatal retinopathy in newborns 1 to improve CCHD screening in newborns2 and when used for continuous monitoring with Masimo Patient SafetyNet ™ * in postoperative wards to reduce activations and costs for rapid response. 3,4,5 Masimo SET ® is used is estimated at more than 100 million patients in leading hospitals and other health care facilities around the world, 6 including in 17 of the top 20 hospitals in the US News and World Report Best Hospitals Honor Roll 2017-18 (US Honorary List of Best Hospitals by US News & World Report) are listed. 7 In 2005, Masimo introduced the rainbow ® technologypresented for pulse CO oximetry. This allowed for non-invasive, continuous monitoring of components of the blood that previously required invasive procedures: hemoglobin (SpHb ® ), oxygen (SpOC ™), carboxyhemoglobin (SpCO ® ), methemoglobin (SpMet ® ), Pleth Variability Index (PVi ® ) and, more recently, Oxygen Reserve Index (ORi ™) in addition to SpO 2 , Pulse Rate and Perfusion Index (Pi). In 2014, Masimo provided Root ® with an intuitive platform for patient monitoring and networking using the Masimo Open Connect ® (MOC-9 ®), which enables other companies to upgrade Root with new features and measurement capabilities. Masimo also takes active leadership in mHealth with products such as the Radius-7 ® portable patient monitor, iSpO 2 ® smart phone pulse oximeter, and the MightySat ™ fingertip pulse oximeter. More information about Masimo and its products can be found at www.masimo.com . The clinical trials published on Masimo products are available at http://www.masimo.com/evidence/featured-studies/feature/ .
ORi has no FDA 510 (k) approval and is not for sale in the US.
* The use of the Patient SafetyNet trademark is licensed from the University HealthSystem Consortium.
literature
1. |
Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO 2Technology. Acta Paediatr . 2011 Feb; 100 (2): 188-92. |
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Second |
de-election Granelli A et al. Impact of pulse oximetry screening on the detection of duct congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ . 2009; 8th Jan; 338th |
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Third |
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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4th |
Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Newsletter of the Anesthesia Patient Safety Foundation. Spring-Summer 2012. |
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5th |
McGrath SP et al. Surveillance Monitoring 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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6th | Estimation: Masimo data in the archive. | |||||
7th |
http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview . |
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Forward-looking statements
This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and 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 of future events that are relevant to us and are subject to risks and uncertainties that are difficult to predict and many of which are beyond our control. Therefore, actual results could differ materially and unfavorably from those contained in our forward-looking statements due to various risk factors. These include, but are not limited to, risks associated with our assumptions about repeatability of clinical trial results; Risks related to our view 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 view that Masimo’s breakthrough non-invasive technologies offer cost-effective solutions and unique benefits; and other factors described in the “Risk Factors” section of the latest reports we filed with the Securities and Exchange Commission (“SEC”). These can be obtained for free on the SEC’s website described in the “Risk Factors” section of our current filings with the Securities and Exchange Commission (“SEC”). These can be obtained for free on the SEC’s website described in the “Risk Factors” section of our current filings with the Securities and Exchange Commission (“SEC”). These can be obtained for free on the SEC’s websitewww.sec.gov, While we believe the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove to be correct. All forward-looking statements contained in this press release are expressly qualified in their entirety by the preceding warnings. You are cautioned not to unduly rely on these forward-looking statements, which are for the time being. We undertake no obligation to update, revise or more precisely disclose these statements or the “Risk Factors” contained in our most recent reports to the SEC, whether as a result of new information,
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Contacts
Masimo
Evan Lamb
949-396-3376
elamb@masimo.com