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Medtronic MIRACLE

This article was originally published in The Gray Sheet

Executive Summary

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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