WorldHeart Changes LVAD Development Plan, Cites Medicare Trial Coverage
This article was originally published in The Gray Sheet
Executive Summary
WorldHeart likely will abandon efforts to earn FDA supplemental approval for the Novacor left-ventricular assist device as destination therapy based on results from the INTrEPID trial
You may also be interested in...
RELIANT trial underway
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)...
RELIANT trial underway
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)...
Novacor upgrade
WorldHeart will begin shipping an upgraded version of the left-ventricular assist device in the U.S. and Canada by the end of March, the company notes in a Jan. 7 release announcing FDA approval of the enhancements. Already approved in Canada and Europe, improvements include quieter pump operation, a smaller, longer-lasting battery and a smaller, quieter battery charger, according to the firm. Novacor is FDA-approved as a bridge to transplant, and will be the subject of a 250 to 300-patient destination therapy trial this year (1"The Gray Sheet" Nov. 10, 2003, p. 39)...