RELIANT trial underway
This article was originally published in The Gray Sheet
Executive Summary
FDA clearance of IDE permits first 50 patients to be enrolled in U.S. trial comparing WorldHeart'sNovacor left-ventricular assist system with Thoratec's HeartMate XVE.The full trial, intended to support a PMA supplement for Novacor as a destination therapy in transplant-ineligible patients, will enroll 225 patients in up to 40 centers, pending further review by FDA. HeartMate is the only LVAD approved for destination therapy in the U.S. (1"The Gray Sheet" Nov. 10, 2003, p. 39)...