Thoratec Pushes Back Approval Timeline For HeartMate II After FDA Meeting
This article was originally published in The Gray Sheet
Executive Summary
Thoratec has pushed back the expected approval timeframe for its HeartMate II continuous flow left ventricular assist device following a "100-day" meeting with FDA on May 1
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HeartMate II PMA
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"...
HeartMate II PMA
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"...
ACC In Brief
Thoratec's HeartMate II: Thoratec expects FDA to approve its continuous-flow left-ventricular assist device as a "bridge to transplant" in heart failure patients this summer. Results of a 133-patient pivotal trial, submitted to FDA in December, were announced at the American College of Cardiology Scientific Sessions in New Orleans March 24-27 by Leslie Miller, M.D., Georgetown University. In the trial, 75% of patients met the primary endpoint of remaining eligible for transplant for at least 180 days or completing a cardiac transplant. Compared to adverse event rates observed in the clinical trials of Thoratec's first-generation HeartMate VE, the rate of percutaneous lead infections declines 90%, stroke is down 50%, and bleeding requiring surgery is down 40%. "The safety profile is really the most important [finding]," Jeff Nelson, president of Thoratec's cardiovascular division, told "The Gray Sheet." Thoratec expects to finish a trial to support a "destination therapy" indication for HeartMate II by the middle of this year (1"The Gray Sheet" Jan. 1, 2007, In Brief)...