Thoratec’s HeartMate II goes to panel
This article was originally published in The Gray Sheet
Executive Summary
FDA Circulatory System Devices advisory panel review of Thoratec's PMA for its second-generation left-ventricular assist device is tentatively set for Nov. 30, the company announces Aug. 15. The company is seeking a bridge-to-transplant indication for the HeartMate II continuous-flow LVAD based on data from a study of 279 patients, including 194 who have reached the 180-day pivotal endpoint (1"The Gray Sheet" Aug. 6, 2007, In Brief). The company also has enrolled 377 patients in a HeartMate II trial for destination therapy...