Thoratec completes HeartMate PMA
This article was originally published in The Gray Sheet
Executive Summary
Firm submits the last module of the PMA for its HeartMate II next-generation, rotary-flow left ventricular assist system seeking approval for patients waiting for heart transplants on Dec. 22. The filing is based on data from 133 bridge-to-transplantation patients who used the device from one to 568 days. A trial is ongoing for the device as a destination therapy (1"The Gray Sheet" May 1, 2006, p. 12)...
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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)...
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