Masimo Oximeters and Neonatal Sensors Receive FDA 510(k) Clearance with Labeling for Use in Newborn Screening for Critical Congenital Heart Disease (CCHD)

IRVINE, Calif., Sept. 24, 2012 /PRNewswire/ -- Masimo (NASDAQ: MASI) announced today that it has received U.S. FDA 510(k) clearance for Masimo Signal Extraction Technology^® (SET^®) pulse oximeters, rainbow^® SET^® Pulse CO-Oximeters^®, and neonatal sensors with labeling for screening newborns for critical congenital heart disease (CCHD).  Masimo SET^® pulse oximeters and sensors have previously been cleared to measure oxygen saturation and pulse rate during motion and low perfusion conditions in newborns, but this marks the first time the FDA has cleared specific labeling indicating the use of pulse oximeters, in conjunction with a physical exam, to screen newborns for CCHD.

In conjunction with the FDA clearance, Masimo also announced the HEART Program (Help Ensure Access to the Right Technology) for CCHD screening enabling 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.

CCHD causes up to 3% of all infant deaths in the first year of life.¹  According to the U.S. Department of Health and Human Services (HHS), these types of heart defects affect about 7 to 9 of every 1,000 live births, one quarter of which could be detected and potentially treated by measuring blood oxygen saturation.  FDA clearance comes as California recently became the latest state to mandate CCHD pulse oximetry screening (http://www.aroundthecapitol.com/Bills/AB_1731/20112012/), following HHS's September 2011 action to add pulse oximetry CCHD screening for newborns as part of the Recommended Uniform Screening Panel.

HHS took this action based on the published findings of the CCHD Workgroup,² which relied on two major independent, published, prospective clinical studies that exclusively used Masimo SET^® Measure-Through Motion and Low Perfusion pulse oximeters to recommend screening with "motion-tolerant pulse oximeters" that "have been validated in low perfusion conditions."  Both of the studies were submitted by Masimo to the FDA to support the new CCHD screening labeling.

• Dr. Anne de-Wahl Granelli, et al., reported on the results of screening 39,821 newborn subjects at five maternity centers in Sweden. Investigators used the Masimo Radical™ with Masimo SET^® technology, and found pulse oximetry screening of all well babies in maternity units is practically feasible with a minimum use of nursing time, and that it significantly improves detection of duct dependent heart disease before hospital discharge. The low false positive rate, the fact that other important pathology is unearthed by the screening, and the likely reduced need for preoperative neonatal intensive care suggest that such screening will be cost effective.³
• Dr. Andrew Ewer, et al., studied 20,055 newborn subjects at six maternity centers in the UK. Investigators used the Radical-7^® with Masimo rainbow^® SET^® technology and found pulse oximetry to be a safe, feasible test that adds value to existing screening. It identifies cases of critical congenital heart defects that go undetected with antenatal ultrasonography, and the early detection of other diseases is an additional advantage.⁴

In spite of the wide availability of Masimo SET^® pulse oximetry, both as standalone products as well as integrated products in over 100 multiparameter monitors from over 50 brands, some hospitals still do not have Masimo SET^® technology.  Given the strong evidence supporting the use of Masimo SET pulse oximetry for CCHD screening and Masimo's commitment to help save and improve babies' lives through expanded CCHD screening programs, the company's HEART Program (Help Ensure Access to the Right Technology) for CCHD screening will help ensure that hospitals have access to Masimo SET technology for CCHD screening.

"We are very proud of where we have taken pulse oximetry," stated Masimo founder and CEO, Joe Kiani.  "Before SET pulse oximetry, CCHD screening was impractical, if not impossible with pulse oximetry.  Dr. Graneli's initial study showed that even a so called 'next generation' pulse oximeter wasn't able to reliably work for CCHD screening, and was abandoned in the middle of the trial, while Masimo SET delivered the groundbreaking results of high sensitivity and specificity that became the basis for this new standard of care.  We are truly elated with this new FDA clearance.  We feel that with it, comes the responsibility to make CCHD pulse oximetry screening more accessible for infants, the most defenseless patients in any healthcare setting.  We are excited to announce that, in conjunction with this new FDA clearance, we are launching the HEART Program for CCHD screening—offering a free Masimo SET® pulse oximeter to hospitals that need one but can't afford it.  In this way, we are helping to address unmet needs on behalf of newborns around the world."

The Masimo pulse oximeters that were the subject of this 510(k) clearance are the Radical-7^®, Rad-57™ and Rad-87™ Pulse CO-Oximeters with Masimo rainbow SET, and the Rad-5^®, Rad-5v™ and Rad-8^® Pulse Oximeters with Masimo SET.

* Hospitals must be located in a country where Masimo has a presence.  Offer subject to rules and regulations of the country where the hospital is located.  Full program details and eligibility requirements available at:  www.masimo.com/heartprogram.

¹ 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

² 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; Volume 128, No. 5; November 2011; e1-w10 DOI: 10.1542/peds.2011-1317. Available here

³ De-Wahl Granelli et al., "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.

⁴ Ewer et al., "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.

Additional references: 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. 

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.

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 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 (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. 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.

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:
Mike Drummond
Masimo Corporation
Phone: (949) 297-7434
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.

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