{"id":43715,"date":"2014-06-17T19:15:27","date_gmt":"2014-06-17T23:15:27","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=news&#038;p=43715"},"modified":"2014-06-17T19:15:27","modified_gmt":"2014-06-17T23:15:27","slug":"fda-approves-second-generation-heart-valve-from-edwards-lifesciences","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2014\/06\/17\/fda-approves-second-generation-heart-valve-from-edwards-lifesciences\/","title":{"rendered":"FDA Approves Second-Generation Heart Valve from Edwards Lifesciences"},"content":{"rendered":"<p>The next phase of the burgeoning and rapidly maturing\u00a0transcatheter aortic valve replacement (TAVR) market has begun.\u00a0Edwards Lifesciences\u00a0<a href=\"http:\/\/www.edwards.com\/newsroom\/Pages\/NR20140616.aspx\">announced<\/a>\u00a0on Monday afternoon that the FDA had approved its second-generation Sapien XT TAVR device\u00a0\u00a0for the treatment of high-risk and inoperable patients suffering from severe symptomatic aortic stenosis (AS).<\/p>\n<p>The Sapien XT is the successor to the first-generation Sapien device, which offered the first nonsurgical approach to\u00a0aortic valve replacement. A competing device,\u00a0Medtronic&#8217;s\u00a0CoreValve, was approved earlier this year and has gained considerable interest. The Sapien XT is expected to be more competitive, in part because of its lower profile and the availability of a 29-mm valve size for patients with a larger native annulus.<\/p>\n<p>Edwards said the Sapien XT will be immediately available along with its accompanying transfemoral, transapical, and transaortic delivery systems.<\/p>\n<p>\u201cThere is a substantial and growing body of evidence that the SAPIEN XT valve benefits both high-risk and inoperable patients, and clinicians have documented these consistently positive results in both randomized studies and European country registries,\u201d said Martin Leon, the co-principal investigator for the PARTNER II Trial, which evaluated the SAPIEN XT valve, in a press release. \u201cThe results from the PARTNER II Trial in treating U.S. inoperable patients with the SAPIEN XT valve demonstrated a reduction in complications with the TAVR procedure, and improved patient outcomes over earlier trials.\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The next phase of the burgeoning and rapidly maturing\u00a0transcatheter aortic valve replacement (TAVR) market has begun.\u00a0Edwards Lifesciences\u00a0announced\u00a0on Monday afternoon that the FDA had approved its second-generation Sapien XT TAVR device\u00a0\u00a0for the treatment of high-risk and inoperable patients suffering from severe symptomatic aortic stenosis (AS). The Sapien XT is the successor to the first-generation Sapien device, [&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":[424,710,912,770],"class_list":["post-43715","post","type-post","status-publish","format-standard","hentry","category-cardiac-surgery","category-interventional-cardiology","tag-aortic-valve-replacement","tag-corevalve","tag-sapien","tag-tavr"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/43715","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=43715"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/43715\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=43715"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=43715"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=43715"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}