THORATEC'S BI-VENTRICULAR ASSIST DEVICE INDICATION FOR EMERGENCY CASES
This article was originally published in The Gray Sheet
Executive Summary
THORATEC'S BI-VENTRICULAR ASSIST DEVICE INDICATION FOR EMERGENCY CASES would give the company entrance to a niche market for which no other ventricular assist devices are approved. At a Dec. 5 meeting in Gaithersburg, Maryland, FDA's Circulatory System Devices Panel unanimously voted to recommend approval of the device as a bridge-to-transplant as long as certain labeling changes are made and postmarket surveillance performed.