Thoratec HeartMate VE
This article was originally published in The Gray Sheet
Executive Summary
PMA supplement submission for left ventricular assist device's long-term use in heart patients on drug therapy who are ineligible for transplant is announced Oct. 18, slightly ahead of company's previously projected November filing timeframe. The submission is based on the NIH-sponsored, 128-patient REMATCH study, results of which will be presented Nov. 12 at the American Heart Association Scientific Sessions 2001 in Anaheim, California. The system currently is approved as a bridge-to-transplant
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