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New Multi-Center Study Finds Masimo SET Pulse Oximetry Screening Significantly Improves Detection of Congenital Heart Disease in Newborns
Date:1/30/2009

Study Published in British Medical Journal Indicates Masimo SET May Also Reduce the Need for Pre-Operative Neonatal Intensive Care and Prevent Long-term Neurological Morbidity

IRVINE, Calif., Jan. 30 /PRNewswire-FirstCall/ -- Masimo (Nasdaq: MASI), the inventor of Pulse CO-Oximetry and Measure-Through Motion and Low Perfusion pulse oximetry, today announced that a new multi-center study of 39,821 newborns was published in the January 2009 issue of the British Medical Journal (BMJ). When compared to a cohort group of 108,604 newborns in whom no pulse oximetry screening was used, the study found that the addition of Masimo SET pulse oximetry screening before discharge increased detection of Congenital Heart Disease (CHD) by 28% (from 72% to 92%). In addition, researchers noted that "no baby died from undiagnosed duct dependent circulation" in the Masimo SET group, while five babies from the cohort group died during the same period.(1)

In the study, Anne de-Wahl Granelli, M.D., of the Queen Silvia Children's Hospital in Goteborg, Sweden, and colleagues screened babies born between 2004 and 2007 at five well baby nurseries using Masimo SET pulse oximetry. A positive pulse oximetry result was defined as an oxygen saturation of <95% measured both preductally (right hand) and postductally (either foot), or a measurement difference >3% between the two measurements. The study found that the positive predictive value of pulse oximetry screening was at least seven times higher than the best-case scenario for standard neonatal physical examination alone (20.7% vs. 3.1%).

Undiagnosed CHD presents devastating long-term morbidity and mortality risks, with 10-30 percent of the babies who die from CHD remaining undiagnosed until autopsy.(2) Additionally, study authors noted that the rise in the proportion of babies who leave the hospital with undiagnosed critical CHD had multiple contributing factors, such as earlier discharge from maternity wards, the growing prevalence of babies rooming with their mothers instead of observational nurseries and reductions in pre-discharge neonatal clinical exams.

The researchers concluded that Masimo 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 CHD. Researchers also commented that "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."

The current study adds to previous research conducted by Dr. Granelli, which demonstrated that when compared to conventional pulse oximetry, only Masimo SET pulse oximetry is accurate and reliable for improving the detection of critical CHD.(3)

Masimo Executive Vice President of Medical Affairs Dr. Michael O'Reilly, stated: "Undiagnosed CHD frequently places the lives of newborns in grave danger. To ensure that these newborns are given the absolute best chance at survival, pre-discharge CHD detection and diagnosis is critical. The comprehensive population and protocol data gathered by these researchers demonstrate that the superior sensitivity and specificity of Masimo SET pulse oximetry technology is key to substantially increasing the ability to accurately diagnose CHD before newborns are discharged from the hospital."

(1) Anne 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." BMJ. 2009; 338;a3037. Available online at: http://www.bmj.com/cgi/content/full/338/jan08_2/a3037

(2) Bonnet D, Coltri A, Butera G, Fermont L, Le Bidois J, Kachaner J, et al., "Detection of transposition of the great arteries in fetuses reduces neonatal morbidity and mortality." Circulation 1999;99:916-8.

(3) Anne de-Wahl Granelli, et al., "Screening for Duct-dependent Congenital Heart Disease with Pulse Oximetry: A Critical Evaluation of Strategies to Maximize Sensitivity.." Acta Paediatrica. 2005; 94:1590-1596.

About Masimo

Masimo (NASDAQ: MASI) develops innovative 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(R), 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 Masimo Rainbow SET(R) Pulse CO-Oximetry(TM), a breakthrough noninvasive blood constituent monitoring platform that can measure many blood constituents that previously required invasive procedures. Masimo Rainbow SET continuously and noninvasively measures total hemoglobin (SpHb(TM)), oxygen content (SpOC(TM)), carboxyhemoglobin (SpCO(R)), methemoglobin (SpMet(R)), and PVI(TM), in addition to oxyhemoglobin (SpO2), pulse rate (PR), and perfusion index (PI), allowing early detection and treatment of potentially life-threatening conditions. Founded in 1989, Masimo has the mission of "Improving Patient Outcomes 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 the positive results and clinical outcomes achieved in this study will be repeated in other studies, and risks related to our assumption that Masimo pulse oximetry technologies and devices will deliver a sufficient level of sensitivity for improved CHD detection over alternative methods of newborn screening to allow for rapid adoption of the technology, as well as other factors discussed in the "Risk Factors" section of our Quarterly Report on Form 10-Q for the fiscal quarter ended September 27, 2008, filed with the Securities and Exchange Commission ("SEC") on October 29, 2008, 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 forward-looking statements or the "Risk Factors" contained in our Quarterly Report on Form 10-Q for the fiscal quarter ended September 27, 2008, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

    Contact:
    Dana Banks
    Masimo Corporation
    949-297-7348

Masimo, SET, Signal Extraction Technology, Improving Outcomes and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, Rainbow, SpHb, SpOC, SpCO, SpMet, PVI, Radical-7, Rad-87, Rad-57,Rad-9, Rad-8, Rad-5,Pulse CO-Oximetry and Pulse CO-Oximeter are trademarks or registered trademarks of Masimo Corporation.


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