Pulse Oximetry Screening Hailed as the 'New Milestone' to Combat Critical Congenital Heart Disease - Signal Extraction Technology Leading the Way in Large, Independent Clinical Studies

IRVINE, Calif., July 17, 2012 /PRNewswire/ -- Pulse oximetry screening is a "new milestone" in the war on critical congenital heart disease (CCHD), one of the most common causes of infant deaths worldwide, according to a recent editorial in The Lancet and accompanying meta-analysis of studies including 229,421 babies.

The meta-analysis by Drs. Andrew Ewer and Shakila Thangaratinam, and colleagues Kiritrea Brown, Javier Zamora, and Khalid S Khan, pooled the results of 13 separate studies and reported the sensitivity of pulse oximetry to detect babies with CCHD at 76.5% (67.7 – 83.5%) and specificity to identify babies without CCHD at 99.9% (99.7 – 99.9%), a significant improvement over existing approaches. The authors noted that three recent large studies (1,2,3) "used motion-tolerant sensors, which function in states of low perfusion", a reference to the use of Masimo Signal Extraction Technology (SET).

The Lancet editorial noted that each year in the United States, some 40,000 babies are born with congenital heart disease and about 4,800 have CCHD, requiring invasive procedures in the first 28 days of life. Fetal ultrasound often fails to adequately detect CCHD, discovering the ailment only 15%-50% of the time. The editorial concluded that "... surely the question now is not 'why should pulse oximetry screening be introduced?' but 'why should such screening not be introduced more widely?'" At the time of publication, The Lancet reported 16 states in the U.S. had either passed or introduced legislation for CCHD pulse oximetry screening.

CCHD screening gained wide exposure in a recent CNN news story, which describes the rationale for and benefits of pulse oximetry screening for CCHD detection. The piece includes clinical experts, product application examples using a SET pulse oximeter and sensor, and chronicles the devastating effect when a baby's CCHD is not detected at birth.

Joe Kiani, Founder and CEO of Masimo, stated: "It's time to screen every newborn. Screening with SET Pulse Oximetry has proven to not only save lives and families the unnecessary death due to CCHD, but it has been shown to be cost effective. Indeed, the best way to improve patient care and reduce cost of care is through medical innovations like these."

(1) de Wahl Granelli A, Wennergren M, Sandberg K, et al. Impact of pulse oximetry screening on detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ 2009; 338: a3037.

(2) Ewer AK, Middleton LJ, Furmston AT, et al. Pulse oximetry screening for congenital heart defects in newborn infants (PulseOx): a test accuracy study. Lancet 2011; 378: 785–94.

(3) Meberg A, Andreassen A, Brunvand L, et al. Pulse oximetry screening as a complementary strategy to detect critical congenital heart defects. Acta Pediatr 2009; 98: 682–86.

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, the company introduced Masimo 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 also 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.

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 assumptions of the repeatability of clinical results obtained using the new Masimo Pronto-7 and noninvasive sensor sizes, risks related to our belief that the Pronto-7 enables quick and easy noninvasive spot-checking of hemoglobin (SpHb®), SpO2, pulse rate, and perfusion index at the point-of-care for all patients, 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 Contact:
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Masimo Corporation
Phone: (949) 297-7434
Email: [email protected]

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