This article was originally published in The Gray Sheet
NYHA Class II heart failure patients appear to benefit from cardiac resynchronization therapy devices, according to results from Medtronic's MIRACLE ICD-II study, published in the Nov. 2 issue of Circulation. The 168-patient study showed that Class II patients treated with CRT-D devices exhibited a 58% improvement in a composite clinical endpoint at six months, compared with 36% for control patients, who received a CRT-D device with the CRT pacing function turned off. The company plans to combine the MIRACLE ICD-II study with data from other CRT studies, including the ongoing 500-patient REVERSE study, to expand the FDA-approved indication for CRT devices to include Class II patients. Class II represents about 2 mil. patients in the U.S. and 40% of all heart failure patients. Currently, CRT therapy is approved for Class III and IV patients (1"The Gray Sheet" June 2, 2003, p. 11)...
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