NEUCHATEL, SWITZERLAND -- (Marketwired) -- Masimo (NASDAQ: MASI), maker of breakthrough Masimo SET® Measure-through Motion and Low Perfusion(tm) Pulse Oximetry, today announced the CE Mark of Eve(tm) Newborn Screening Software Application* for Radical-7® Pulse CO-Oximeters. Eve is designed to help clinicians more effectively and efficiently screen newborns for critical congenital heart disease (CCHD).
Newborn screening protocols may sometimes present challenges, among them: longer-than-necessary monitoring times, misapplication of sensors, calculation errors, and confusion interpreting results.
The Eve Newborn Screening Software Application in the Radical-7 Pulse CO-Oximeter automates the screening steps with animated instruction, including sensor application, measurement selection, and screening result determination.
Institutions can also choose to add the Perfusion Index (PI) measurement available in all Masimo SET® pulse oximeters to the screening criteria, which has been shown to identify CCHD or other illnesses not identified by physical exam or by SpO2 measurements alone.1
Use of the Eve Newborn Screening Software Application is intended to:
- Provide consistent application of the screening protocol to reduce method and operator-induced variability
- Improve efficiency by automating the data capture and comparison between readings.
CCHD is an umbrella term for a group of severe heart defects. All forms of CCHD affect the flow of blood into, out of, or through the heart, and if not detected and treated soon after birth can be deadly. CHD causes up to 3% of all infant deaths in the first year of life.2 According to the U.S. Department of Health and Human Services (HHS), congenital heart defects affect up to 9 of every 1,000 live births, one quarter of which could be detected and potentially treated by measuring blood-oxygen saturation with Measure-through Motion and Low Perfusion Pulse Oximetry -- a quick, noninvasive, and inexpensive test that helps clinicians screen for potential CCHD that may signal the need for additional testing before a newborn leaves the hospital.
In 2011, an expert workgroup formed under the auspices of the HHS Secretary's Advisory Committee on Heritable Disorders in Newborns and Children recommended newborn screening with Measure-through Motion and Low Perfusion Pulse Oximetry to increase the detection of CCHD.3 The CCHD workgroup cited the results of two large and independent prospective studies of 59,876 subjects that exclusively used Masimo SET® Measure-through Motion and Low Perfusion Pulse Oximetry4,5 to increase the identification of CCHD with minimal false positives.
In 2014, a third large, independent study of 122,738 newborns that also exclusively used Masimo SET® pulse oximetry showed similar, positive results as the first two large studies.6
Dr. Anne de-Wahl Granelli -- lead author on the groundbreaking CCHD study, liaison to the U.S. Department of Health and Human Services Secretary's Advisory Committee on Heritable Diseases in Newborns and Children (SACHDNC) workgroup, and author of an award-winning doctoral thesis in this field -- has stated: "While working at one of the two centers in Sweden that performed pediatric cardiac surgery, I found a significant difference, when compared simultaneously with blood gas, between Masimo SET and all other pulse oximetry technologies we used on cyanotic children in the PICU and pediatric cardiac ward. We were not aware of the significant difference between oximeters before this clinical study. And, as a result, we upgraded all our pulse oximeters to Masimo SET."
"Too many babies have been discharged from hospitals without proper pulse oximetry screening, only to die or require last-minute, emergency life-saving procedures," said Annamarie Saarinen, co-founder and CEO of the Newborn Foundation, and the mother of Eve, who was diagnosed at 48 hours old with CCHD. "Failing to follow and interpret a proper screening protocol, as well as being able to read measurements in newborns who are often in motion and have low perfusion are factors that can make CCHD screening with pulse oximetry a challenge. The data and study evidence show that having the right pulse oximetry technology for CCHD screening is critical -- and it's very exciting to see the introduction of Eve, a new tool that offers nurses a clearer, safer, more efficient way to conduct newborns screening and protect newborn lives."
"When we started Masimo 25 years ago, the code name for our first technology, Measure-through Motion and Low Perfusion Pulse Oximetry, was Stork. We named it Stork because we had hoped that we could with this technology help clinicians and parents deliver babies safely to their home," said Joe Kiani, founder and CEO of Masimo. "Annamarie and her daughter Eve have inspired us to name the new automated CCHD detection application, Eve. Annamarie has worked tirelessly to make CCHD screening the standard of care worldwide. We salute her and Dr. Granelli, and hope that Eve will help these professionals accomplish their mission to help save the lives of babies and spare families from heartbreaking loss."
This application is not available in the United States.
* Referred to as "CCHD Mode" in Radical-7
1 de-Wahl Granelli A et al. Acta Paediatr. 2007 Oct;96(10):1455-9.
2 Secretary of Health & Human Services letter to the Secretary's Advisory Committee on Heritable Disorders in Newborns and Children (SACHDNC); dated September 21, 2011. Available here.
3 Kemper, et al. Pediatrics. 2011
4 de-Wahl Granelli A., et al. BMJ. 2009 Jan 8;338
5 Ewer AK et al. Lancet. 2011 Aug 27;378(9793):785-94
6 Zhao Q-m, Ma X-j, Ge X-l, Liu F, Yan W-l, Wu L, Ye M, Liang X-c, Zhang J, Gao Y, Jia B, Huang G-y, Neonatal Congenital Heart Disease screening group. Pulse oximetry with clinical assessment to screen for congenital heart disease in neonates in China: a prospective study. The Lancet, Early Online Publication, 23 April 2014. doi:10.1016/S0140-6736(14)60198-7
Masimo (NASDAQ: MASI) is the global leader in innovative noninvasive monitoring technologies that significantly improve patient care-helping solve "unsolvable" problems. In 1995, the company debuted Measure-Through Motion and Low Perfusion pulse oximetry, known as Masimo SET®, which virtually eliminated false alarms and increased pulse oximetry's ability to detect life-threatening events. More than 100 independent and objective studies have shown that Masimo SET® outperforms other pulse oximetry technologies, even under the most challenging clinical conditions, including patient motion and low peripheral perfusion. In 2005, Masimo introduced rainbow SET® 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(tm)), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and Pleth Variability Index (PVI®), in addition to SpO2, pulse rate, and perfusion index (PI). Additional information about Masimo and its products may be found at www.masimo.com.
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 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 belief that Masimo SET® improves CCHD detection in newborns before hospital discharge, risks related to our assumptions of the repeatability of clinical results obtained, and risks related to our assumptions that Masimo SET® pulse oximetry technology improves patient outcomes, 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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