{"id":39043,"date":"2013-09-23T17:28:35","date_gmt":"2013-09-23T21:28:35","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=news&#038;p=39043"},"modified":"2013-09-23T17:28:35","modified_gmt":"2013-09-23T21:28:35","slug":"using-registry-data-fda-expands-indication-for-edwards-sapien-transcatheter-heart-valves","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2013\/09\/23\/using-registry-data-fda-expands-indication-for-edwards-sapien-transcatheter-heart-valves\/","title":{"rendered":"Using Registry Data, FDA Expands Indication for Edwards&#8217; Sapien Transcatheter Heart Valves"},"content":{"rendered":"<p>Relying on an important new source of information, the FDA\u00a0<a href=\"http:\/\/www.fda.gov\/NewsEvents\/Newsroom\/PressAnnouncements\/ucm369510.htm\">said<\/a>\u00a0today that it had expanded the label for the Sapien Transcatheter Heart Valve (Edwards Lifesciences). Previously, the Sapien was approved for insertion via the transfemoral or transapical access points in patients not eligible for traditional aortic valve surgery. The new labeling no longer mentions access points and therefore allows for alternative access points such as the subclavian.<\/p>\n<p>The most significant part of the FDA&#8217;s announcement may be not the label change itself but the source of the data supporting the claim\u00a0\u2014 the Transcatheter Valve Therapy Registry (TVTR). The TVTR, which is run by the American College of Cardiology and the Society of Thoracic Surgeons, has emerged as an model of cooperation between the FDA, industry, and medical organizations.\u00a0The TVTR data, according to the FDA, show no evidence that the access point changed the benefit-risk profile or the device.<\/p>\n<p>\u201cJust two years after the THV entered the market for a specific patient population, data from the TVTR was used to support FDA approval that expands patient access to a life-saving therapy,\u201d said Jeffrey Shuren, the director of the FDA\u2019s Center for Devices and Radiological\u00a0Health, in an FDA press release. \u201cMedical device registries like the TVTR not only play an important role in the FDA\u2019s post market surveillance system, they also collect robust and timely data that can be used to identify additional patient populations that benefit from the therapy. \u201c<\/p>\n<p>\u201cLeveraging clinical research inside the framework of a device registry to expand access to therapy for more patients is a new paradigm for the FDA, researchers, registry sponsors and the medical device industry,\u201d said Shuren. \u201cWe believe this approach can be used with future well-designed device registries to speed patient access to important, well-evaluated therapies.\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Relying on an important new source of information, the FDA\u00a0said\u00a0today that it had expanded the label for the Sapien Transcatheter Heart Valve (Edwards Lifesciences). Previously, the Sapien was approved for insertion via the transfemoral or transapical access points in patients not eligible for traditional aortic valve surgery. The new labeling no longer mentions access points [&hellip;]<\/p>\n","protected":false},"author":196,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1,9],"tags":[424,196,423,770],"class_list":["post-39043","post","type-post","status-publish","format-standard","hentry","category-general","category-interventional-cardiology","tag-aortic-valve-replacement","tag-fda","tag-tavi","tag-tavr"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/39043","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=39043"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/39043\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=39043"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=39043"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=39043"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}