Thoratec
This article was originally published in The Gray Sheet
Executive Summary
PMA supplement filed with FDA seeks approval of the Thoratec ventricular assist device (VAD) for use as a bridge-to-recovery in treatment of late stage heart failure. The application includes data on 36 patients, 23 of whom recovered the use of their natural heart after being supported by the device from ten to 190 days. The Thoratec VAD system already is approved for biventricular support as both a bridge-to-transplant and for post-cardiotomy recovery of the heart in patients who are unable to be weaned from cardiopulmonary bypass following open-heart surgery