{"id":33198,"date":"2012-11-21T21:37:25","date_gmt":"2012-11-22T02:37:25","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=news&#038;p=33198"},"modified":"2012-11-21T21:37:25","modified_gmt":"2012-11-22T02:37:25","slug":"heartware-lvad-approved-by-fda-for-transplant-patients","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2012\/11\/21\/heartware-lvad-approved-by-fda-for-transplant-patients\/","title":{"rendered":"HeartWare LVAD Approved By FDA For Transplant Patients"},"content":{"rendered":"<p>The FDA\u00a0<a href=\"http:\/\/www.fda.gov\/NewsEvents\/Newsroom\/PressAnnouncements\/ucm328818.htm\">said<\/a>\u00a0today that it had granted approval to the HeartWare Ventricular Assist System for use in heart failure patients waiting for a transplant. Approval of the device had been expected after\u00a0<a title=\"FDA Advisory Panel Gives Green Light to HeartWare Ventricular Assist System\" href=\"http:\/\/blogs.nejm.org\/cardioexchange\/news\/fda-advisory-panel-gives-green-light-to-heartware-ventricular-assist-system\/\">the FDA\u2019s Circulatory System Devices panel recommended approval of\u00a0the device<\/a>\u00a0earlier this year.<\/p>\n<p>HeartWare was approved based on data from the pivotal ADVANCE trial, in which 140 patients received the Heartware device and were compared to historical controls who had received Thoratec\u2019s HeartMate II device. The FDA said this was the first time it had approved an LVAD using registry data as a control.\u00a0Unlike Thoratec&#8217;s HeartMate II VAS, which is surgically implanted in an abdominal pouch, the HeartWare VAS is implanted next to the heart.<\/p>\n<p>The FDA said that surgical outcomes were comparable in the two groups. Because of the risk of stroke associated with the device, the FDA said patients and clinicians should &#8220;discuss all treatment options before deciding to use the device.&#8221;<\/p>\n<p>HeartWare <a href=\"http:\/\/ir.heartware.com\/phoenix.zhtml?c=187755&amp;p=irol-newsArticle&amp;ID=1760867&amp;highlight=\">said<\/a> that the FDA was requiring the company to perform a post-approval study in the form of \u00a0a registry consisting of 600 HeartWare patients \u00a0and an additional 600 control patients. The FDA will also require sites that implant the device to undergo training with an approved program.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The FDA\u00a0said\u00a0today that it had granted approval to the HeartWare Ventricular Assist System for use in heart failure patients waiting for a transplant. Approval of the device had been expected after\u00a0the FDA\u2019s Circulatory System Devices panel recommended approval of\u00a0the device\u00a0earlier this year. HeartWare was approved based on data from the pivotal ADVANCE trial, in which [&hellip;]<\/p>\n","protected":false},"author":196,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[20,14,9],"tags":[1573,1235,554,1572,1236],"class_list":["post-33198","post","type-post","status-publish","format-standard","hentry","category-cardiac-surgery","category-heart-failure","category-interventional-cardiology","tag-heartmate","tag-heartware","tag-lvad","tag-lvas","tag-ventricular-assist-device"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/33198","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=33198"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/33198\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=33198"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=33198"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=33198"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}