{"id":12628,"date":"2011-10-17T13:59:52","date_gmt":"2011-10-17T17:59:52","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=news&#038;p=12628"},"modified":"2011-10-17T13:59:52","modified_gmt":"2011-10-17T17:59:52","slug":"sapien-transcatheter-heart-valve-might-be-delayed","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2011\/10\/17\/sapien-transcatheter-heart-valve-might-be-delayed\/","title":{"rendered":"Sapien Transcatheter Heart Valve Might Be Delayed"},"content":{"rendered":"<p>Approval for the highly anticipated Sapien transcatheter aortic heart valve might be delayed for 6 months, until April 2012. The FDA had been expected to reach a decision this month. But now a member of the FDA advisory panel that recommended approval for Sapien, Jeffrey Borer, in a public statement made at the ACC\/AATS Heart Valve Summit in Chicago, said that FDA approval would be delayed until April. Borer\u2019s remarks were reported by Wells Fargo medical device analyst Larry Biegelsen, who said he believed that Borer was only speculating and that the most likely scenario is that Sapien will gain approval this month.<\/p>\n<p><a href=\"http:\/\/moneywatch.bnet.com\/investing\/news\/edwards-down-on-report-of-fda-delay-co-disputes\/6316159\/\">An Edwards spokesperson told the Associated Press<\/a> that the company still anticipates Sapien&#8217;s approval in October.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Approval for the highly anticipated Sapien transcatheter aortic heart valve might be delayed for 6 months, until April 2012. The FDA had been expected to reach a decision this month. But now a member of the FDA advisory panel that recommended approval for Sapien, Jeffrey Borer, in a public statement made at the ACC\/AATS Heart [&hellip;]<\/p>\n","protected":false},"author":196,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[20,9],"tags":[912,423,770],"class_list":["post-12628","post","type-post","status-publish","format-standard","hentry","category-cardiac-surgery","category-interventional-cardiology","tag-sapien","tag-tavi","tag-tavr"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/12628","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=12628"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/12628\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=12628"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=12628"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=12628"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}