New Study Shows that Masimo SET Pulse Oximetry May be a Valuable Clinical Tool for Diagnosis of Congenital Heart Disease in Newborns


New Low Cost Method for Detecting Heart Defects in Newborns Could Save Many Lives

IRVINE, Calif., Feb. 22 // -- Masimo, the inventor and leader of Pulse CO-Oximetry and read-though motion and low perfusion pulse oximetry, announced that a recent study, published in Acta Peadiatrica, shows that Masimo SET pulse oximetry is effective in detecting duct dependent congenital heart disease in infants. Recently even the Wall Street Journal reported on the gravity of this situation. Many newborns that are sent home die within days or are forever handicapped from congenital cardiovascular defects that are undetected before discharge. At home, these babies seem to be suffering from flu, but they are suffering from congenital cardiovascular defects. If properly detected before discharge, most of these babies can get treatment and lead normal lives.

The study, "Screening for Duct Dependent congenital heart disease with Pulse Oximetry: A critical evaluation of strategies to maximize sensitivity," outlines a relatively low cost method of using Masimo SET pulse oximetry to potentially diagnose congenital cardiovascular defects, with very high levels of sensitivity and specificity. The same study also showed that pulse oximeters without Masimo SET performance, fall woefully short of being useful tools for such diagnosis.

Congenital cardiovascular defects are problems with the structure or formation of the heart and major blood vessels, which occur while a fetus' heart is developing in the womb. According to the American Heart Association, congenital cardiovascular defects, also known as congenital heart disease, are the most common type of congenital malformations in newborns, present in about 1 percent of live births. Congenital cardiovascular defects range in severity with some being lethal within hours or days of birth unless diagnosed and treated. However, large numbers of these defects go undetected by routine neonatal physical examinations. In fact, 10 to 30 percent of newborn deaths from congenital cardiovascular defects in the first year are due to cases that go undetected. With advances in treatment, including the ability to perform open heart surgery on neonates as young as one day old, prognosis for newborns diagnosed with some forms of congenital cardiovascular defects is excellent, indicating that improved detection has the potential to save many lives.

In a study done by researchers from the Institute of Women's and Children's Health at the University of Gothenberg, Sweden, a new and powerful method for detecting duct dependent congenital heart defects has been described. By measuring the newborn's oxygen level in the right hand and one foot, simultaneously, with Masimo SET pulse oximetry and using specific criteria, the researchers showed that congenital cardiovascular defects could be detected with more than 90% confidence. For the study, the researchers also performed this testing with another pulse oximeter, the GE Datex Ohmeda TuffSat. However, the GE pulse oximeter obtained reliable readings in only 76% of patients. In contrast, the Masimo SET Radical pulse oximeter obtained reliable readings in 100% of the patients. Thus the researchers concluded that the non Masimo SET pulse oximeter could not be used as a screening device. The authors stated, "The data in our study clearly show that a high-performance new-generation oximeter with improved performance during low perfusion states and resistance to motion artifacts is the key to enable screening with both a high sensitivity and a low false positive rate."

Michael Liske, MD, Pediatric Cardiologist at Vanderbilt University stated, "This exciting technology has the potential for screening asymptomatic newborn infants for critical congenital heart defects. Other technologies have been limited by their sensitivity, perhaps related to errors related to patient motion, the very issue that Masimo SET addresses. The Masimo SET pulse oximeter would be the ideal tool for use in a large scale study to determine if universal screening should be implemented."

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. Over 100 clinical studies have confirmed that Masimo SET technology allows clinicians to accurately monitor blood oxygen saturation in critical care situations. In 2005 Masimo introduced Rainbow SET and with it, 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 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.

Source: Masimo

CONTACT: Brad Langdale of Masimo, +1-949-297-7009, blangdale@masimo.com

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

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