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New labeling for Medtronic CRT

This article was originally published in The Gray Sheet

Executive Summary

Revised labeling cleared by FDA for Medtronic's cardiac resynchronization therapy devices without defibrillation will reflect the technology's reduced risk of mortality and hospitalization. The labeling expansion is based upon results from the 813-patient CARE-HF trial of the firm's InSync and InSync III CRT-P devices, presented in 2005 (1"The Gray Sheet" Sept. 12, 2005, p. 13). The data, showing a 36%-40% reduction in all-cause mortality, provides validation that CRT devices "should be routinely used in patients with moderate to severe heart failure," William Abraham, MD, Ohio State University, says...
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