October 28th, 2011

FDA Advisory Panel Votes 8-2 Against Approval of Medtronic AF Ablation System

An FDA advisory panel has recommended against approval of Medtronic’s Ablation Frontiers Cardiac Ablation System for the treatment of symptomatic, drug refractory, persistent atrial fibrillation (AF) or longstanding persistent AF of up to four years in duration.

In an 8-2 vote, members of the Circulatory System Devices Panel said that the risks of the device outweighed its benefits. Earlier the panel had unanimously agreed that the device was effective in combating AF, but voted 9-1 that it was not safe.

In a report prepared for the committee, the FDA reviewers had expressed grave concerns about the safety of the system, focusing particular concern on the high stroke rate.

In his Twitter feed, Mark McCarty, of Medical Device Daily, pointed out that all catheter ablation for AF other than paroxysmal is off-label. The panel, he said, sent a signal to electrophysiologists that they should continue using other devices off label.

The Wall Street Journal quoted panel chair Clyde Yancy, who is holding out hope for eventual approval of the device: “I hope what you heard today is not a no, but a not yet.”

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