IRVINE, Calif., Nov. 14 /PRNewswire-FirstCall/ -- Masimo , the inventor of Pulse CO-Oximetry and Read-Through Motion and Low Perfusion pulse oximetry, reported that a new independent and objective clinical study demonstrates the ability of Masimo SET Perfusion Index (PI) to improve detection of congenital heart defects (CHD) in newborns with duct-dependent systemic circulation. Even when routine neonatal physical examinations and saturation screenings fail, PI may help to accurately detect CHD-enabling life-saving early detection and critical intervention before discharge from the hospital. It has been documented that up to 30% of all deaths from CHD in the first year of life are due to unrecognized cases being discharged to the home.
PI is a measurement featured in the Masimo Rainbow SET technology platform that reflects the real-time changes in peripheral blood flow at the monitored site and the strength of the plethysmographic signal displayed on the pulse oximeter. In addition to improving the detection of CHD in infants, the ability to noninvasively and continuously measure PI could enable faster identification of clinically significant changes in a patient’s physiologic status, including potentially hypothermia, hypovolemia, shock and/or sepsis.
In the study, entitled “Noninvasive Peripheral Perfusion Index as a Possible Tool for Screening for Critical Left Heart Obstruction,” conducted at the Institute of Clinical Sciences, Gothenburg University, Sweden, A de-Wahl Granelli and I Ostman-Smith observed whether PI was a dependable indicator in critically-ill newborns to enable its use for congenital heart disease screening purposes. The researchers indicated that several studies have reported that babies with congenital heart disease are not detected by routine neonatal physical examinations and that neonatal screening fails mainly in children with duct-dependent systemic circulation.
Granelli and Ostman-Smith conducted single pre- and postductal measurements of PI using the Masimo Radical SET Pulse Oximeter in a total of 10,000 healthy newborns (ranging in age from 1 hour to five days) and established PI reference values of healthy babies. In establishing reference values that validate possible PI indices for normal vs. disease state in newborns, researchers were able to show that low PI values may correspond to illness.
Study results showed that combined neonatal examination and oxygen saturation screening detected only 78% of the newborns with LHOD, but when PI was added, 100% of all newborns with LHOD showed abnormalities -- indicating that PI may reflect abnormal blood flow from the heart in CHD newborns. All LHOD newborns had either pre- or postductal PI values below the interquartile cut-off value of 1.18 and five had values below a potential cut-off of 0.70, leading researchers to conclude that “PI values lower than 0.70 may indicate illness and a value less than 0.50 indicates definite underperfusion.”
Study findings suggest that a combination of saturation screening cut-offs with PI value cut-offs may help improve the early detection of congenital heart defects that have duct-dependent systemic circulation. As a result, researchers concluded that PI is a “promising tool for improving the detection of critical congenital heart disease with duct-dependent systemic circulation."(1)
Joe E. Kiani, Chairman and CEO of Masimo stated, “When we introduced Masimo SET ten years ago, we knew that the improved accuracy and fidelity would allow clinicians to more tightly control the arterial oxygen levels of their patients, but it is truly remarkable to see research like this where our technology is being used to improve screening for congenital heart defects. We are all indebted to clinicians like these from Gothenburg University who are constantly looking for ways to utilize the latest technological advancements to deliver better care.”
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 Masimo SET, and with it virtually eliminated false alarms and increased pulse oximetry’s ability to detect life-threatening events. More than 100 independent and objective studies have confirmed that Masimo SET technology allows clinicians to accurately monitor blood oxygen saturation in critical care situations. Our Masimo SET platform has significantly addressed many of the previous technology limitations, has substantially contributed to improved patient outcomes and has been referred to by several industry sources as the gold standard in pulse oximetry. 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. 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 http://www.masimo.com.
Forward Looking Statements
This press release may include forward-looking statements. These forward-looking statements are based on current expectations about future events affecting us and are subject to uncertainties and factors, all of which are difficult to predict and many of which are beyond our control, including: risks related to our assumption that the results of the PI study will be duplicated in future clinical studies and risks related to our assumptions regarding the correlation between PI and abnormal blood flow from the heart in CHD newborns, as well as changes in a patient’s physiologic status, and other factors discussed in the “Risk Factors” section of our quarterly report on Form 10-Q for the quarter ended September 29, 2007, filed with the Securities and Exchange Commission on November 1, 2007. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. 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 quarter ended September 29, 2007, whether as a result of new information, future events or otherwise, except as may be required under the federal securities laws.
Masimo, SET, Signal Extraction Technology, Radical, Radical-7, Rad-57, APOD, Improving Outcomes and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, Rainbow, SpCO, SpMet, and Pulse CO-Oximeter are trademarks or registered trademarks of Masimo Corporation.
CONTACT: Tom McCall of Masimo Corporation, +1-949-297-7075
Web site: http://www.masimo.com/
