HeartMate II trial fully enrolled
This article was originally published in The Gray Sheet
Executive Summary
Thoratec completes enrollment for the bridge-to-transplantation arm of its HeartMate II left ventricular assist system, implanting 133 patients. The May 31 announcement notes recent FDA approval to enroll up to 90 additional patients, which Thoratec says will not impact the timing of a planned PMA submission for the device. Enrollment is ongoing for the 200-patient destination therapy arm of the trial comparing HeartMate II with HeartMate XVE in end-stage heart failure patients who don't qualify for a transplant (1"The Gray Sheet" May 1, 2006, p. 12)...