Circulatory Panel Warms To Cardiac Freezor Despite Missed Trial Targets
This article was originally published in The Gray Sheet
Executive Summary
CryoCath Technologies' Freezor is approvable, with conditions, for cardiac cryoablation despite failing to meet pre-determined safety and efficacy endpoints, FDA's Circulatory System Devices Panel concluded in a 7-3 vote March 6 in Gaithersburg, Md