{"id":3188,"date":"2010-10-19T12:51:52","date_gmt":"2010-10-19T17:51:52","guid":{"rendered":"http:\/\/www.heart-valve-surgery.com\/heart-surgery-blog\/?p=3188"},"modified":"2018-08-31T07:46:42","modified_gmt":"2018-08-31T12:46:42","slug":"corevalve-aortic-valve-replacement-trial","status":"publish","type":"post","link":"https:\/\/www.heart-valve-surgery.com\/heart-surgery-blog\/2010\/10\/19\/corevalve-aortic-valve-replacement-trial\/","title":{"rendered":"Medtronic Gets FDA Approval For CoreValve Percutaneous Aortic Valve Replacement Trial"},"content":{"rendered":"<p>Interest in catheter-based technologies for heart valve repair and heart valve replacement continues to skyrocket.<\/p>\n<p>As you have seen, we recently (i) reviewed new data for the SAPIEN aortic valve replacement and (ii) observed a <a href=\"https:\/\/www.heart-valve-surgery.com\/mitraclip\/\">MitraClip case for mitral valve repair<\/a>. Recently, I learned that Medtronic, one of the leading heart valve manufacturers, received FDA approval for its investigational device exemption application. That means that Medtronic can conduct a patient trial to determine the safety and efficacy of its percutaneous CoreValve system for <a href=\"https:\/\/www.heart-valve-surgery.com\/aortic-valve-replacement-surgery.php\">aortic valve replacement<\/a>.<\/p>\n<p>&nbsp;<\/p>\n<p style=\"text-align: center;\"><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter\" src=\"\/Images\/aortic-stenosis-corevalve-percutaneous.jpg\" alt=\"Severely Stenotic Aortic Heart Valve \" width=\"230\" height=\"208\" \/>Aortic Stenosis &#8211; Narrowed Trileaflet Valve<\/p>\n<p>&nbsp;<\/p>\n<p><!--more--><\/p>\n<p>Like the Edwards SAPIEN heart valve replacement, the CoreValve is a minimally invasive procedure intended for high-risk patients that <a href=\"https:\/\/www.heart-valve-surgery.com\/aortic-stenosis-valve-heart-narrowing.php\">suffer from aortic stenosis<\/a>. The trial will enroll 1,200 patients at 40 clinical sites, according to Medtronic. Key metrics that the study will track are:<\/p>\n<ul>\n<li>Mortality rates one-year after implant<\/li>\n<li>Stroke incidence<\/li>\n<li>Days of hospitalization<\/li>\n<\/ul>\n<p>The CoreValve heart valve replacement device received a CE mark in March, 2007 and has already been implanted in over 12,000 patients suffering from aortic stenosis across 34 countries. As you might recall, CoreValve was purchased by Medtronic for $700 million last year.<\/p>\n<p>When I learn the details of the trial, I&#8217;ll make sure to pass it along to everybody. Again, this is a very exciting time for heart valve treatment.<\/p>\n<p>Keep on tickin!<br \/>\nAdam<\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":25417,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[28],"tags":[],"class_list":["post-3188","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-aortic-valve-replacement"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/www.heart-valve-surgery.com\/heart-surgery-blog\/wp-json\/wp\/v2\/posts\/3188","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.heart-valve-surgery.com\/heart-surgery-blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.heart-valve-surgery.com\/heart-surgery-blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.heart-valve-surgery.com\/heart-surgery-blog\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.heart-valve-surgery.com\/heart-surgery-blog\/wp-json\/wp\/v2\/comments?post=3188"}],"version-history":[{"count":0,"href":"https:\/\/www.heart-valve-surgery.com\/heart-surgery-blog\/wp-json\/wp\/v2\/posts\/3188\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.heart-valve-surgery.com\/heart-surgery-blog\/wp-json\/wp\/v2\/media\/25417"}],"wp:attachment":[{"href":"https:\/\/www.heart-valve-surgery.com\/heart-surgery-blog\/wp-json\/wp\/v2\/media?parent=3188"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.heart-valve-surgery.com\/heart-surgery-blog\/wp-json\/wp\/v2\/categories?post=3188"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.heart-valve-surgery.com\/heart-surgery-blog\/wp-json\/wp\/v2\/tags?post=3188"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}