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Breaking Multi-Center Study: Masimo SET Pulse Oximetry Technology,Shown to Significantly Lower Instances of Severe Retinopathy of,Prematurity in Extremely Low Birth Weight Infants

Study released at the Pediatric Academic Societies' Annual Meeting This Month in Toronto Shows That Switching to Masimo SET Pulse Oximetry Technology Can Reduce the Risk Associated with ROP by 40%

IRVINE, Calif., May 30, 2007 /PRNewswire/ -- Masimo, the inventor of Pulse CO-Oximetry and Read-Through Motion and Low Perfusion pulse oximetry, reported that a new independent study presented at the Pediatric Academic Societies' (PAS) Annual Meeting in Toronto, Canada earlier this month showed that switching to Masimo SET pulse oximetry technology can reduce the risk of extremely low birth weight (ELBW) infants developing retinopathy of prematurity (ROP) by 40%.(1) One of the most common causes of visual impairment and blindness in premature infants, ROP has been shown to be exacerbated by hyperoxia caused by the excessively high levels of supplemental oxygen often used to treat these patients, due in large part to unreliable oxygen level measurements from pulse oximeters not able to maintain accuracy during conditions of motion and low perfusion.

In the study entitled Clinical Practice and SpO2 Technology in the Prevention of ROP in ELBW Infants, a team of neonatologists from hospitals in Georgia, Texas and New Jersey headed by Armando Castillo, Richard Deulofeut, and Augusto Sola examined whether a change in pulse oximetry (SpO2) technology could impact treatment effect and relative risk reduction of ROP in ELBW infants. "The impact of (differences in pulse oximetry technologies) in reducing ROP is not easy to discriminate" the researchers stated in the study. "Infants under our care were exposed to a unique situation, where a universal change in clinical practice was implemented by the same health care team members, but SpO2 technology after the clinical change was not uniform."

As a result, the research team was able to analyze ROP rates before and after identical clinical practice changes at two di fferent Health Care Centers and isolate the difference made by the pulse oximetry technology. The clinical changes included increased education and commitment of bedside care givers along with guidelines to decrease hyperoxemic periods and wide changes in oxygenation. Nellcor N395 pulse oximeters, with claims of accuracy during motion and low perfusion, were used in both Centers prior to the clinical practice changes, while after these changes Center #1 switched to Masimo SET pulse oximetry and Center #2 kept the Nellcor technology.

In Center #1, pre-change rates from 2000-2002 for ROP (III and IV) and laser treatments were 11.1% and 4% respectively, decreasing to 6% and 2.5% in 2003-2004 after the change in clinical practice and switch to Masimo SET -- representing a 40% relative risk reduction in severe ROP. For the same time periods in Center #2, ROP (III and IV) and laser treatment rates remained unchanged at 13% and 5% respectively after changing clinical practice and maintaining use of Nellcor N395 technology, leading researchers to state that the results were "significantly more favorable" for the center that switched to Masimo technology.

"In a large group of examined inborn infants <1,250 grams treated by the same neonatologists, MDs and NNPs using the same clinical guideline to decrease hyperoxemia and wide changes in oxygenation, the relative risk rate of severe ROP and laser therapy are associated with the SpO2 technology utilized," the researchers concluded. "This further supports the significance of adequate SpO2 monitors in managing critically ill infants."

Joe E. Kiani, Chairman and CEO of Masimo stated; "In 2002, a group of researchers at Cedars Sinai led by Dr. Sola published a ground-breaking study, which showed that a new oxygen titration protocol, including the monitoring of the neonates' arterial blood oxygen saturation with Masimo SET pulse oximetry, could dramatically reduce ROP. But some observers questioned how critical Masimo SET pulse oximetry was to the success of the protocol. This multi-center study shows that the accuracy and reliability of Masimo SET pulse oximetry, in the hands of caring clinicians with sound protocol, is indeed important to achieving dramatic reductions in ROP."

About Masimo

Masimo develops innovative monitoring technologies that significantly improve patient care -- helping solve "unsolvable" problems. In 1995, the company debuted Read-Through Motion and Low Perfusion pulse oximetry, known as SET and with it virtually eliminated false alarms and increased pulse oximetry's ability to detect life-threatening events. More than 100 independent clinical studies have confirmed that Masimo SET technology allows clinicians to accurately monitor blood oxygen saturation in critical care situations -- establishing the technology as the "gold standard" pulse oximetry and substantially contributing to improved patient outcomes. In 2005 Masimo introduced Masimo Rainbow SET Pulse CO-Oximetry, which, for the first time, noninvasively monitors the level of carbon monoxide and methemoglobin in the blood, allowing early detection and treatment of potentially life-threatening conditions. Masimo, founded in 1989, 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 http://www.masimo.com.

    (1) Clinical Practice and SpO2 Technology in the Prevention of ROP in ELBW

        Infants. Armando R. Castillo, Richard Deulofeut, Augusto Sola.

        Publication 8440.7; 2007 Pediatric Academic Societies'


    Contact:

    Tom McCall

    Masimo Corporation

    949-297-7075

Masimo, SET, Signal Extraction Technology, Radical, Radical-7, Rad57, APOD, and Improving Outcomes and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications are registered trademarks of Masimo Corp. ARM, Acoustic Respiratory Monitoring, BiFi, Rainbow, SpCO, SpMet, SpHb and Pulse CO-Oximeter are trademarks of Masimo Corp.

CONTACT: Tom McCall of Masimo Corporation, +1-949-297-7075

Web site: http://www.masimo.com/

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