Masimo Continues Its Advocacy on Behalf of Newborns During Congenital Heart Defects (CHD) Awareness Week Although Pulse Oximetry Screening Gains Ground, Most Infants Go Unscreened in the U.S.
IRVINE, Calif., Feb. 15, 2013 /PRNewswire/ -- Congenital Heart Defects (CHD) are the leading cause of infant deaths – affecting about 1 in 125 babies.1,2 In the U.S., one in three infants with a potentially life-threatening CHD leaves the hospital undiagnosed.3
Early detection through pulse oximetry screening and intervention are keys to saving the lives of babies with CHDs.4 The screening determines the amount of oxygen in the blood and pulse rate. It is inexpensive, noninvasive, and fast. As part of Congenital Heart Defect Awareness Week (Feb. 7-14), Masimo (NASDAQ: MASI) continued to advocate for pulse oximetry screening of all newborns by demonstrating proper sensor placement during the America Heart Association's "Heart on the Hill Day" in St. Paul, Minn., earlier this week. Minnesota is joining a growing number of states that are enacting or have enacted legislation that require screening newborns for Critical Congenital Heart Disease (CCHD) prior to discharge from hospitals. To date, California, Connecticut, Delaware, Indiana, Maryland, New Hampshire, New Jersey, Tennessee and West Virginia have enacted such legislation, according to the Newborn Coalition.
Although screening newborns with Measure-Through Motion and Low Perfusion Masimo SET® pulse oximetry has been shown to increase CCHD detection by 34%,4 CCHD screening is not currently included in most state newborn screening panels, according to the Centers for Disease Control and Prevention.
Recognizing the growing need for universal CCHD screening and the "emerging evidence base for the utility of early diagnosis and detection of CCHD via measurement of blood oxygen saturation," the U.S. Department of Health and Human Services (HHS) made CCHD screening by pulse oximetry a nationwide standard by adding it to the Recommended Uniform Screening Panel (RUSP) Guidelines in 2011. Federal guidelines recommend pulse oximetry screening with "motion-tolerant pulse oximeters" that "have been validated in low perfusion conditions."5
To effectively screen for CCHD, using the right technology matters. Last year Masimo received FDA 510(k) clearance for SET® pulse oximeters, rainbow® Pulse CO-Oximeters®, and neonatal sensors with labeling for screening newborns for CCHD. This marked the first time the FDA cleared specific labeling indicating the use of pulse oximeters, in conjunction with a physical exam, to screen newborns for CCHD.
Validation of SET®'s advantage for CCHD screening is provided in a 2005 study by Dr. Anne de Wahl Granelli that evaluated the sensitivity of various SpO2 cut points for CCHD screening. In the study, Dr. Granelli evaluated a SET® and non-SET pulse oximeter which has been referred to as "next generation" technology (GE Ohmeda Tuffsat).6 The "next generation" technology resulted in 41% of post-ductal SpO2 values below 95%, while the SET® pulse oximeter recorded only 1%.7 The high number of false positives with non-SET pulse oximetry led Dr. Granelli to abandon use of it and focus exclusively on signal extraction technology with SET® pulse oximeters for future CCHD studies. This result is not surprising, given that CCHD screening is often performed during motion and low perfusion.
To ensure that hospitals have the right technology in place to perform CCHD screening on newborns, Masimo announced the HEART Program (Help Ensure Access to the Right Technology). It enables hospitals in countries where Masimo has a presence that want to perform CCHD screening with a Masimo SET® pulse oximeter, but do not have one and do not have funds to purchase one, to receive a free Masimo SET® pulse oximeter. More details are available at www.masimo.com/heartprogram. Offering the HEART program internationally provides an opportunity to help solve the global CCHD burden around the world as health officials from the United Arab Emirates (UAE) to Beijing (China) and the UK have embraced Masimo pulse oximetry screening of newborns for CCHD.
"Early on Masimo SET® technology, because of its ability to measure-through motion, was an instrumental part of the protocol that dramatically reduced neonatal eye damage and Retinopathy of Prematurity in countless newborns," said Joe Kiani, founder and CEO of Masimo. "Now we are seeing Masimo technology play an increasing role in the early detection of CCHD in newborns, which is helping save precious lives and spare families the soul-crushing pain of losing an infant. For Masimo, every week is CHD Awareness Week."
To download the Action Plan to Address Failure to Detect Critical Congenital Heart Disease (CCHD) presented at this year's Patient Safety, Science & Technology Summit, please visit: http://www.patientsafetysummit.org/challenges/challenge-6-cchd-screening-in-newborn-infants.aspx
Also available online, Masimo's Newborn CCHD Screening Step-by-Step Instructional Guide, which provides another helpful resource to clinicians and hospitals looking to implement CCHD screening in their institutions. Visit: http://www.masimo.com/heartprogram/documents/LAB6252B_Sales_Tool_CCHD_Screening_Adhesive_Sensor.pdf
1 National Heart, Lung and Blood Institute. Congenital Heart Defects. December 2007.
2 Congenital Cardiovascular Defects: Current Knowledge: A Scientific Statement From the American Heart Association Council on Cardiovascular Disease in the Young. Circulation, volume 115, June 12, 2007, pages 2995-3014.
3 Wren C, Reinhardt Z, Khawaja K. Twenty-year trends in diagnosis of life-threatening neonatal cardiovascular malformations. Arch Dis Child Fetal Neonatal Ed. 2008;93:F33–F35.
4 Andrew K Ewer, Lee J Middleton, Alexandra T Furmston, Abhay Bhoyar, Jane P Daniels, Shakila Thangaratinam, Jonathan J Deeks, Khalid S Khan. "Pulse oximetry screening for congenital heart defects in newborn infants (PulseOx): a test accuracy study." The Lancet 2011: Vol. 378; No. 9793; pp 785-794. Available here.
5 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 .
7 de Wahl Granelli A et al. Acta Paediatr. 2005 Nov;94(11):1590-1596.
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 required invasive procedures, including total hemoglobin (SpHb®), oxygen content (SpOCTM), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and Pleth Variability Index (PVI®), in addition to SpO2, pulse rate, and perfusion index (PI). In 2008, Masimo introduced Patient SafetyNet™, a remote monitoring and wireless clinician notification system designed to help hospitals avoid preventable deaths and injuries associated with failure to rescue events. In 2009, Masimo introduced rainbow® Acoustic MonitoringTM, the first-ever noninvasive and continuous monitoring of acoustic respiration rate (RRa™). Masimo's rainbow® SET® technology platform offers a breakthrough in patient safety by helping clinicians detect life-threatening conditions and helping guide treatment options. In 2010, Masimo acquired SedLine®, a pioneer in the development of innovative brain function monitoring technology and devices. In 2012, Masimo acquired assets of Spire Semiconductor, LLC, maker of advanced light emitting diode (LED) and other advanced component-level technologies; and acquired Phasein AB, a developer and manufacturer of ultra-compact mainstream and sidestream capnography, multigas analyzers, and handheld capnometry solutions. Masimo SET® and Masimo rainbow® SET® technologies also can be found in over 100 multiparameter patient monitors from over 50 medical device manufacturers around the world. Founded in 1989, Masimo has the mission of "Improving Patient Outcome and Reducing Cost of Care … by Taking Noninvasive Monitoring to New Sites and Applications®." 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 CHD 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 is a superior solution for CHD detection and newborn screening applications, 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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