Thoratec HeartMate VE
This article was originally published in The Gray Sheet
Executive Summary
Expedited review is granted by FDA for expanded use of the left ventricular assist system as an alternative to transplant. A PMA supplement for the "destination therapy" indication was submitted in October based on recently disclosed REMATCH trial data ("The Gray Sheet" Nov. 19, 2001, p. 15). Review by the agency's Circulatory System Devices Panel is expected prior to FDA approval in mid-2002...