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)...