{"id":12787,"date":"2011-10-28T09:49:12","date_gmt":"2011-10-28T13:49:12","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=news&p=12787"},"modified":"2011-10-28T09:49:12","modified_gmt":"2011-10-28T13:49:12","slug":"fda-advisory-panel-votes-8-2-against-approval-of-medtronic-af-ablation-system","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2011\/10\/28\/fda-advisory-panel-votes-8-2-against-approval-of-medtronic-af-ablation-system\/","title":{"rendered":"FDA Advisory Panel Votes 8-2 Against Approval of Medtronic AF Ablation System"},"content":{"rendered":"

An FDA advisory panel has recommended against approval of Medtronic\u2019s Ablation Frontiers Cardiac Ablation System for\u00a0the treatment of symptomatic, drug refractory, persistent atrial fibrillation (AF) or longstanding persistent AF of up to four years in duration.<\/p>\n

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.<\/p>\n

In a report<\/a>\u00a0prepared\u00a0for the committee, the FDA reviewers had expressed grave concerns about the safety of the system, focusing particular concern on the high stroke rate.<\/p>\n

In his Twitter feed<\/a>, Mark McCarty, of\u00a0Medical Device Daily,\u00a0<\/em>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.<\/p>\n

The Wall Street Journal<\/a>\u00a0quoted panel chair Clyde Yancy, who is holding out hope for eventual approval of the device:\u00a0“I hope what you heard today is not a no, but a not yet.”<\/p>\n","protected":false},"excerpt":{"rendered":"

An FDA advisory panel has recommended against approval of Medtronic\u2019s Ablation Frontiers Cardiac Ablation System for\u00a0the 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 […]<\/p>\n","protected":false},"author":196,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[641,944],"class_list":["post-12787","post","type-post","status-publish","format-standard","hentry","category-electrophysiology","tag-af-ablation","tag-fda-advisory-committee"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/12787","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/users\/196"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/comments?post=12787"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/12787\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=12787"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=12787"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=12787"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}