{"id":875,"date":"2009-07-25T08:51:48","date_gmt":"2009-07-25T13:51:48","guid":{"rendered":"http:\/\/www.heart-valve-surgery.com\/heart-surgery-blog\/2009\/07\/25\/medtronic-melody-catheter-pulmonary-heart-valve-replacement\/"},"modified":"2018-09-03T10:21:50","modified_gmt":"2018-09-03T15:21:50","slug":"medtronic-melody-catheter-pulmonary-heart-valve-replacement","status":"publish","type":"post","link":"https:\/\/www.heart-valve-surgery.com\/heart-surgery-blog\/2009\/07\/25\/medtronic-melody-catheter-pulmonary-heart-valve-replacement\/","title":{"rendered":"Medtronic&#8217;s Melody Heart Valve Replacement Technology Gets FDA Support"},"content":{"rendered":"<p>As we have discussed, the competitive market for minimally invasive heart valve replacements and heart valve repair continues to heat up.<\/p>\n<p>Earlier this week, we learned more about Edwards&#8217; SAPIEN technology. Then came this interesting story about Medtronic and its Melody transcatheter pulmonary heart valve replacement solution. Did you see this?<\/p>\n<p>The <em>Associated Press<\/em> reported that federal health advisers unanimously backed an experimental <a href=\"https:\/\/www.heart-valve-surgery.com\/heart-valve-replacement.php\">heart valve replacement solution<\/a> from Medtronic as a safe and effective treatment for patients with a rare heart defect.<\/p>\n<p>&nbsp; <\/p>\n<p style=\"text-align: center;\"><img loading=\"lazy\" decoding=\"async\" alt=\"\" src=\"https:\/\/www.heart-valve-surgery.com\/Images\/medtronic-melody-valve.jpg\" width=\"260\" height=\"258\" \/><br \/>\nThe Melody Heart Valve Replacement<\/p>\n<p>&nbsp; <\/p>\n<p>The Food and Drug Administration&#8217;s panel of heart experts voted 12 to 0 in favor of approving the <em>Melody Pulmonary Valve<\/em>, although stent fractures were identified during the study. According to <em>The Wall Street Journal<\/em>, the FDA said <a href=\"https:\/\/www.heart-valve-surgery.com\/heart-surgery-blog\/2008\/05\/22\/stents-in-heart-valve-replacements\/\">stents<\/a> &#8211; which are a part of the Melody device &#8211; fractured in 18% of patients in the study. The concern about such fractures is that parts of the device could break off and result in blood clots. Ultimately, the FDA believes there is a &#8220;low probability&#8221; that such fragments would cause blood clots.<\/p>\n<p><!--more--><\/p>\n<p>The endorsement was made on the condition that Medtronic conducts a follow-up study of the device&#8217;s safety.<\/p>\n<p><em>Medtronic<\/em>, the world&#8217;s largest medical device maker, has asked the FDA to approve the device for adults and children with a heart defect that disrupts blood flow between the hearts right chambers and the lungs. The valve is designed to be implanted using a small catheter, known as the Ensemble (shown below), thereby eliminating the need for open heart surgery.<\/p>\n<p>&nbsp; <\/p>\n<div style=\"text-align: center;\"><img loading=\"lazy\" decoding=\"async\" alt=\"\" src=\"https:\/\/www.heart-valve-surgery.com\/Images\/melody-heart-valve.jpg\" width=\"276\" height=\"299\" \/><br \/>\nThe Ensemble Transcatheter Delivery System<\/div>\n<p>&nbsp; <\/p>\n<p>&#8220;The Melody valve attempts to decrease the total surgical burden on a patient,&#8221; said Dr. John Liddicoat, a vice president with Medtronic. Other benefits of this minimally invasive approach include:<\/p>\n<p>According to <em>MedGear<\/em>, Medtronic has already received approval from the Europe\u2019s CE Mark for its Melody Transcatheter Pulmonary Valve developed for the congenital heart patients to treat pulmonary valve insufficiency.<\/p>\n<p>The first patient to receive a Melody pulmonary heart valve replacement occurred on February 19, 2007 during a clinical trial.<\/p>\n<p>Keep on tickin!<br \/>\nAdam<\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":26584,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[37],"tags":[],"class_list":["post-875","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-heart-valve-replacement"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/www.heart-valve-surgery.com\/heart-surgery-blog\/wp-json\/wp\/v2\/posts\/875","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=875"}],"version-history":[{"count":0,"href":"https:\/\/www.heart-valve-surgery.com\/heart-surgery-blog\/wp-json\/wp\/v2\/posts\/875\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.heart-valve-surgery.com\/heart-surgery-blog\/wp-json\/wp\/v2\/media\/26584"}],"wp:attachment":[{"href":"https:\/\/www.heart-valve-surgery.com\/heart-surgery-blog\/wp-json\/wp\/v2\/media?parent=875"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.heart-valve-surgery.com\/heart-surgery-blog\/wp-json\/wp\/v2\/categories?post=875"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.heart-valve-surgery.com\/heart-surgery-blog\/wp-json\/wp\/v2\/tags?post=875"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}