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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
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