U.S. Health & Human Services Makes Critical Congenital Heart Defect Screening Using Motion-Tolerant Pulse Oximetry a Nationwide Newborn Screening Standard

IRVINE, Calif., Sept. 23, 2011 /PRNewswire/ -- Masimo (NASDAQ: MASI) announced today that the U.S. Department of Health & Human Services (HHS) has added Critical Congenital Heart Defects (CCHD) screening using motion-tolerant pulse oximetry as a national newborn screening standard.  In addition, the largest UK study of pulse oximetry screening for CHD detection, published online in the Lancet (appearing in the November 2011 print edition), demonstrates that when Masimo SET® Measure-Through Motion and Low Perfusion pulse oximetry was used to screen newborns before hospital discharge, it enabled clinicians to increase CHD detection and provided a cost-effective method for universal screening with high sensitivity.(1)

An International Problem—Undetected / Undiagnosed CHD in Newborns

Among the approximately 4.2 million babies born in the U.S. annually,(2) CHD is the most prevalent form of birth defect and is the #1 cause of infant death.(3)  HHS estimates that approximately 7-9 babies per 1,000 live births have some form of CHD.(3)  Yet, up to 30% of infant deaths from CHD occurred before diagnosis(4)—leading many to question the effectiveness of current newborn screening methods. Current methods of CHD detection rely largely on newborn physical examination but fail to identify approximately 50% of CHD cases(5)—leaving many vulnerable newborns undiagnosed at hospital discharge.

The Strategy for a Nationwide Solution—"Motion-Tolerant Pulse Oximetry"

In a letter dated September 21, 2011, HHS Secretary Kathleen Sebelius outlined the decision to adopt expert panel recommendations for universal CCHD screening by pulse oximetry for all newborns into federal Recommended Uniform Screening Panel (RUSP) Guidelines—the national newborn screening system standards and policies.  Citing the "emerging evidence base for the utility of early diagnosis and detection of CCHD via measurement of blood oxygen saturation" and the "momentum and commitment" at the state and federal levels, Sebelius directed federal agencies to "proceed expeditiously with implementation." The federal Agency Plan of Action outlined by HHS calls for the National Institutes of Health (NIH) to fund technology, process, care, and outcomes research activities; the Centers for Disease Control and Prevention (CDC) to fund surveillance activities to monitor infant morbidity and mortality outcomes; and the Health Resources and Services Administration (HRSA) to guide development of screening standards and implementation infrastructure, including training materials.(3)

In August 2011, a panel of pediatric and cardiac experts from the American Academy of Pediatrics (AAP), the American College of Cardiology (ACC), and the American Heart Association (AHA), in conjunction with the HHS Secretary's Advisory Committee on Heritable Disorders in Newborns and Children (SACHDNC), acted on the HHS 2010 recommendation(6) and outlined a strategy for routine screening of newborns to improve detection of CHD.(7)  The 28-page report recommends that newborn screening be done with "motion-tolerant pulse oximeters that report functional oxygen saturation, have been validated in low perfusion conditions, have been cleared by the FDA for use in newborns, and have a 2% root-mean-square accuracy."  The report also outlined a 5-point implementation strategy and follow-up procedures, which includes screening, diagnostic confirmation, electronic results reporting, primary care follow-up, surveillance and tracking.

Gerard R. Martin, M.D., F.A.A.P., F.A.C.C., Senior Vice President of the Center for Heart, Lung and Kidney Disease at Children's National Medical Center in Washington, D.C., stated, "The excellent results that we can now achieve in correcting critical congenital heart defects make timely diagnosis even more important.  Adding pulse oximetry screening as an important adjunct to fetal ultrasound and newborn physical examination will help to ensure that no baby is missed.  This is a major win for babies born with congenital heart diseases, as well as the families and providers who care for them."

Latest Published Study to Show Masimo SET Improves Early CHD Detection in Newborns

In the current Lancet-published study, researchers screened 20,055 asymptomatic newborn babies (gestation >34 weeks) at six UK maternity units using Masimo SET pulse oximetry before discharge. Newborns with oxygen saturation (SpO2) of less than 95% in either limb or a difference of more than 2% between limbs were considered positive for CHD and underwent echocardiography.  Results showed that 53 babies had major CHDs (24 critical)—a prevalence of 2.6 per 1,000 live births.  Masimo SET pulse oximetry achieved sensitivity of 75% (95% CI 53.29–90.23) for critical CHDs (causing death or requiring invasive intervention before 28 days) and 49% (95% CI 35.06–63.16) for all major CHDs (causing death or requiring invasive intervention within 12 months of age.)(1)

Findings also showed that Masimo SET pulse oximetry helped clinicians increase CHD detection by 34% versus antenatal ultrasonography alone (from 35 cases to 53 cases). In addition, out of the 0.8% false-positive results (169), 27% had other problems that required medical intervention (6 were significant but not major congenital heart defects and 40 were other illnesses like respiratory disorders and infections)—showing that the sensitivity of Masimo SET enabled identification of other life-threatening newborn conditions that likely would have otherwise gone undiagnosed.  Researchers concluded that: "Pulse oximetry is a safe, feasible test that adds value to existing screening. It identifies cases of critical congenital heart defects that go undetected with antenatal ultrasonography. The early detection of other diseases is an additional advantage."

According to Dr. Mitchell Goldstein, Neonatologist and Associate Professor of Pediatrics at Loma Linda University Children's Hospital in California, stated, "Congenital heart defects are difficult to detect because many newborns do not show outward signs of failure until they decompensate.  Today, congenital heart disease screening by Masimo SET pulse oximetry represents a safe and inexpensive way to screen for heart disease before the baby has a life-threatening event.  Federal recommendations for universal screening underscore the critical importance of what SET has done to make pulse oximetry a clinically useful tool."

Other Studies Prove: Pulse Oximetry Technology Matters

In addition to the current Lancet-published study, two of the largest CHD studies conducted to date have also shown that Masimo SET is effective in screening newborns for CHD, including a Swedish study of 39,821 newborns published in the British Medical Journal(8) and a Norwegian study of 50,008 newborns published in the Journal of Pediatrics.(9)

Masimo SET (Signal Extraction Technology) is clinically proven in over 100 independent and objective studies to provide the most accurate and reliable SpO2 and pulse rate measurements, even under the most challenging conditions of patient motion and low peripheral perfusion. Utilizing patented signal processing technologies—including parallel engines and adaptive filters—to deliver accurate and reliable measurements of a patient's true oxygenation status, Masimo SET has been shown to reduce false patient monitor alarms by over 95% and expand true alarm detection to over 97%. Because of this superior performance, Masimo SET is the leading Measure-Through Motion and Low Perfusion SpO2 solution incorporated into over 100 multiparameter monitors and 50 monitoring brands—including Atom, Datascope, GE Medical, Medtronic, Philips, Spacelabs, Welch Allyn, and Zoll, among others.

Joe Kiani, Founder, Chairman, and CEO of Masimo, commented that, "We commend HHS, the federal advisory committee, individual states, and the countless medical professional, public health leaders, and advocates that worked so hard to give our nation's smallest and most vulnerable patients a resounding voice. Adding CHD screening by Measure-Through Motion and Low Perfusion pulse oximetry is a significant advancement of our nation's newborn screening standard that will save untold newborn lives and help to prevent the agony of families who are left to cope with the devastating effects of undetected CHD."

To date, because of the overwhelming clinical evidence and appeals by grassroots advocates made up largely of parents with babies affected by CHD, Maryland and New Jersey have passed legislation promoting CHD screening by pulse oximetry in newborns with similar screening initiatives taking place in Beijing, China and the U.K.  For a complete list of states' status on CHD screening legislation, visit:  www.cchdscreeningmap.com.

* Note: Masimo SET technology is not indicated to diagnose or treat congenital heart defects.

Editor's note:

References:

1. 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.

2. Sutton, PD. "Recent trends in births and fertility rates through June 2010." National Center for Health Statistics Health E-Stat 2010. Available at: http://www.cdc.gov/nchs/data/hestat/births2010/births2010.htm

3. 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.

4. De-Wahl Granelli A,Mellander M, Sunnegardh J, Sandberg K,Ostman -Smith I. "Screening for duct-dependent congenital heart disease with pulse oximetry: a critical evaluation of strategies to maximize sensitivity." Acta Paediatr 2005;94:1590-6.  Available here.

5. Wren C, Richmond S, Donaldson L. "Presentation of congenital heart disease in infancy: implications for routine examination." Arch Dis Child Fetal Neonatal Ed. 1999;80:F49–F53.  Available here.

6. Secretary's Advisory Committee on Heritable Disorders in Newborns and Children (SACHDNC); Recommendation Letter to HHS Secretary Kathleen Sebelius; October 15, 2010. Secretary of Health and Human Services; Letter to SACHDNC on CHD Screening Recommendation; April 20, 2011.

7. Alex R. Kemper, William T. Mahle, Gerard R. Martin, W. Carl Cooley, Praveen Kumar, W. Robert Morrow, Kellie Kelm, Gail D. Pearson, Jill Glidewell, Scott D. Grosse, R. Rodney Howell. "Strategies for Implementing Screening for Critical Congenital Heart Disease." Pediatrics; published online ahead of print Aug. 22, 2011.  Available here.

8. Anne de-Wahl Granelli, Margareta Wennergren, Kenneth Sandberg, Mats Mellander, Carina Bejlum, Leif Inganas, Monica Eriksson, Niklas Segerdahl, Annelie Agren, Britt-Marie Ekman-Joelsson, Jan Sunnegardh, Mario Verdicchio, Ingegerd Ostman-Smith.  "Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns." British Medical Journal (BMJ) January 2009; 338:a3037.  Available here.

9. Meberg A, Brugmann-Pieper S., Due R. et al. "First Day of Life Pulse Oximetry Screening to Detect Congenital Heart Defects." Journal of Pediatrics 2008: 761-765. Available here.

About Masimo

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 demonstrate Masimo SET provides the most reliable SpO2 and pulse rate measurements 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 (SpOC™), 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 Monitoring™, 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.  Masimo SET and Masimo rainbow SET technologies can be also 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.

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 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.

Media Contacts:
Dana Banks
Phone: (949) 297-7348
Email: [email protected]

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care... by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI, rainbow Acoustic Monitoring, RRa, Radical-7, Rad-87, Rad-57, Rad-8, Rad-5, Pulse CO-Oximetry, Pulse CO-Oximeter, Adaptive Threshold Alarm, and SEDLine  are trademarks or registered trademarks of Masimo Corporation. The use of the trademarks Patient SafetyNet and PSN are under license from University HealthSystem Consortium.

SOURCE Masimo Corporation

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