HeartMate II PMA
This article was originally published in The Gray Sheet
Executive Summary
Thoratec amends PMA filing for its HeartMate II left-ventricular assist device as a bridge to cardiac transplant in response to an FDA letter outlining deficiencies, the firm announces July 31. The amended filing includes new data from 279 patients, including 194 patients who have reached the 180-day pivotal study endpoint. The original PMA, filed last winter, included data from 133 patients. Following a May meeting with FDA, Thoratec revised its expectation for approval to late 2007 or early 2008 (1"The Gray Sheet" May 7, 2007, p. 13). The company also has enrolled 377 patients in a trial intended to establish HeartMate II as a "destination therapy"...
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