Research In Brief
This article was originally published in The Gray Sheet
Executive Summary
HeartMate II update: Thoratec announces Dec. 4 that it has asked FDA to allow it to eliminate additional randomization in its destination therapy pivotal study of the HeartMate II continuous-flow ventricular assist device. The study protocol called for an interim analysis to test for the superiority of HeartMate II to HeartMate XVE when two-thirds of first 200 patients reached two-years of follow-up. The trial reached 200 patients in May 2007, and Thoratec says the interim analysis shows statistically superior outcomes for patients who received HeartMate II versus those who received the XVE. Since May 2007, the trial has enrolled another 407 patients under a continuous access protocol, including 166 in the randomized portion of the study. The company now hopes to file a PMA application for the destination therapy indication for HeartMate II in the first half of 2009