FDA Panel Backs HeartWare VAS Despite Safety Concerns
April 26, 2012|Cardiology
Author and Disclosure Information
FROM A MEETING OF THE FDA'S CIRCULATORY SYSTEM DEVICES PANEL
If approved, the manufacturer’s postmarketing plans include a study that will continue to evaluate patients in the ADVANCE trial. The HeartWare VAS was approved in the European Union in 2009. It is also being studied as destination therapy, comparing it to the HeartMate II.
The FDA usually follows the recommendations of its advisory panels. Panelists have been cleared of potential conflicts of interest related to the topic of the meeting. Occasionally, a panelist may be given a waiver, but not at this meeting.
