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 News Release - May 9, 2007

Breaking Studies: Masimo SET Pulse Oximetry Technology Shown to Be Most Effective During Neonatal Resuscitation and Valuable in Caring for Extremely Low Birth Weight Infants

Studies Released at the Pediatric Academic Societies' Annual Meeting This Week in Toronto Add to the More Than 100 Independent and Objective Clinical Studies Showing the Superiority of Masimo Pulse Oximetry

IRVINE, Calif., May 9 (HSMN NewsFeed) -- Masimo, the inventor of Pulse CO-Oximetry and Read-Through Motion and Low Perfusion pulse oximetry, reported that three new independent studies presented at the Pediatric Academic Societies' (PAS) Annual Meeting in Toronto, Canada this week reinforced the clinical accuracy and reliability of Masimo SET pulse oximetry under the most difficult clinical conditions, including neonatal resuscitation and heart rate monitoring of extremely low birth weight infants. In one study, Masimo SET was shown to be more than three times faster than competing technologies in its ability to reach a stable and adequate SpO2 reading during neonatal resuscitation(1).

In the study entitled Avoiding Hyperoxemia during Neonatal Resuscitation: Time to Response of Different SpO2 Monitors a team of neonatologists from hospitals in Columbia and New Jersey headed by Herando Baquero, Ramiro Alviz, and Augusto Sola performed a prospective observational analysis of 24 newborns who received resuscitation in unstable conditions in the delivery room and NICU to determine whether if SpO2 can be measured reliably and if the time to stable readings is different between different monitors. The researchers' specific interest was in preventing oxygen overdose or hyperoxemia, which has been linked to neonatal eye damage and even blindness from retinopathy of prematurity (ROP). Researchers compared readings from a Masimo SET Radical to those from two other pulse oximeters and found that the Masimo unit was able to reach a stable oxygen saturation more than three times as fast as the next best pulse oximeter tested.

As a result of this study, the researchers noted that "adequate and clinically useful reading of SpO2 is possible during newborn resuscitation and that "the time to stable and adequate reading is significantly different between SpO2 monitors"-with Masimo shown to have by far the fastest response time. Researchers further concluded that "the SpO2 monitor with the fastest response time would allow for more rapid adjustments of FiO2 (oxygen) during resuscitation and avoid unnecessary exposure to hyperoxia."

In two other studies presented at the PAS meeting in Toronto, both performed by a team of neonatologists including Jennifer Dawson, Omar Kamlin, Colm O'Donnell, Peter Davis and Colin Morley at Royal Women's Hospital in Melbourne, Australia, the researchers set out to determine if the heartrate from a Masimo SET pulse oximeter was reliable enough to guide treatment of extremely low birth weight infants in the delivery room(2,3). The first study entitled How Accurate is Pulse Oximetry in Measuring the Heart Rate (HR) of Newly Born Infants? compared ECG and SpO2 heartrate data from 55 infants and found that on average, measurement of heart rate by Masimo SET matched ECG heartrate, with researchers noting that the Masimo SET showed the highest sensitivity in identifying infants requiring intervention with heartrates below 100 beats per minute.

In the second study, entitled Delivery Room Heart Rate Measurements of Infants Born at 24-28 Weeks Gestation, the researchers noted that although pulse oximetry is widely used to measure oxygen saturation and heart rate in the delivery room, there were no reports about the range of heart rate during neonatal transition of extremely low birth weight infants, adding that heart rate "is an important indicator of the need for, and the response to resuscitation in newly born infants."

Because of this, researchers analyzed heart rate data obtained from 26 premature births using Masimo SET pulse oximeters and determined that "it is feasible to measure heart rate by pulse oximetry in extremely low birth rate infants in the delivery room. Continuous heart rate measured by pulse oximetry may be valuable in guiding the need for and response to resuscitative interventions in the DR and warrants further investigation."

Joe E. Kiani, Chairman and CEO of Masimo stated: "We are very happy to see that researchers around the world continue to use our technology to improve process of care, positively impacting the lives of the most vulnerable patients in the most difficult clinical conditions. The ability to provide clinicians with the information they need to make a difference in the lives of neonatal patients continues to be a great source of pride for the entire Masimo team. Our commitment to neonatal and infant monitoring is evidenced by innovations like our Newborn sensor designed for newborn resuscitation and examination and our Blue sensor, which is specially designed to monitor cyanotic babies with very low oxygen saturation and children with congenital heart defects."

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

(1) Avoiding Hyperoxemia during Neonatal Resuscitation: Time to Response of Different SpO2 Monitors. Hernando Baquero, Ramiro Alviz, Augusto Sola. Neonatology, Universidad Norte, Barranquilla, Atlantico, Colombia; Neonatology, MACSA - Clinica del Mar, Barranquilla, Atlantico, Colombia; Neonatology, Mid Atlantic Neonatology Associates and Morristown Memorial Hospital, Morristown, NJ.

(2) Delivery Room Heart Rate Measurements of Infants Born at 24-28 Weeks Gestation. Jennifer A. Dawson, C. Omar F. Kamlin, Colm P.F. O'Donnell, Peter G. Davis, Colin J. Morley. Neonatal Services, Royal Women's Hospital, Melbourne, Australia.

(3) How Accurate Is Pulse Oximetry in Measuring the Heart Rate (HR) of Newly Born Infants? C. Omar F. Kamlin, Jennifer A. Dawson, Colm P.F. O'Donnell, Jasbir Sekhon, Colin J. Morley, Peter G. Davis. Neonatal Services, The Royal Women's Hospital, Melbourne, Australia.

Tom McCall
Masimo Corporation

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.

Source: Masimo

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