This article was originally published in The Gray Sheet
Executive SummaryMicrovolt level T-wave alternans measured with the firm's CH2000 test system "was the only statistically significant predictor of sudden death" among seven different clinical measures evaluated in a study of 107 congestive heart failure (CHF) patients followed for 18 months, the firm reports. Published in the Aug. 19 issue of The Lancet, the study included patients with no prior history of sustained ventricular arrhythmias. The study shows the technology to be "the most effective non-invasive test to identify [CHF] patients at risk for developing life-threatening abnormal heart rhythms," the firm maintains. The CH2000 system was cleared by FDA in 1996, and labeling was expanded in April 1999 to include the prediction of risk for severe cardiac arrest
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