{"id":45567,"date":"2014-10-13T07:07:32","date_gmt":"2014-10-13T11:07:32","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=news&#038;p=45567"},"modified":"2015-01-05T10:32:17","modified_gmt":"2015-01-05T15:32:17","slug":"first-drug-coated-balloon-approved-by-fda-for-leg-blockages","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2014\/10\/13\/first-drug-coated-balloon-approved-by-fda-for-leg-blockages\/","title":{"rendered":"First Drug-Coated Balloon Approved by FDA for Leg Blockages"},"content":{"rendered":"<p>The FDA today\u00a0<a href=\"http:\/\/www.fda.gov\/NewsEvents\/Newsroom\/PressAnnouncements\/ucm418455.htm\">announced<\/a>\u00a0that it had approved\u00a0for use in the U.S. the first drug-coated angioplasty balloon catheter to re-open blocked arteries in the superficial femoral and popliteal arteries. The Lutonix 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (Lutonix DCB) is manufactured by\u00a0CR Bard\u00a0and has been available in\u00a0Europe\u00a0since 2012.<\/p>\n<p>&#8220;Peripheral artery disease can be quite serious. Preventing further blockage of arteries is just as important as removing the initial blockage\u201d said William Maisel, the deputy director for science and chief scientist in the FDA\u2019s Center for Devices and Radiological\u00a0Health, in an FDA press release. \u201cThe clinical data show that Lutonix DCB may be more effective than traditional balloon angioplasty at helping to prevent further blockage in the artery.\u201d<\/p>\n<p>The Lutonix DCB &#8220;is a new first-line therapy for treating blockages, without closing the door to other treatment options down the road,&#8221;\u00a0said\u00a0Harvard University&#8217;s\u00a0Kenneth Rosenfield, in\u00a0<a href=\"http:\/\/www.crbard.com\/prlanding.aspx?releaseID=1976316\">a CR Bard press release<\/a>. Rosenfield said the new device can also be used &#8220;to\u00a0complement existing therapy options.\u201d<\/p>\n<p>Rosenfield was the principal investigator of the\u00a0LEVANT 2 pivotal study which randomized 101 patients to the Lutonix DCB or conventional balloon angioplasty. At six months, fewer than half the patients treated with conventional therapy did not require additional treatment for their peripheral disease. By contrast, 71.8% of patients in the Lutonix DCB did not need additional treatment.<\/p>\n<p>The FDA is requiring the manufacturer to perform two post-approval studies. The first will monitor the long-term safety and effectiveness of the device in 657 patients. The second is a randomized trial designed to assess the safety and efficacy of the device in women.<\/p>\n<p>Rick Lange was a member of the FDA advisory panel that\u00a0<a href=\"http:\/\/www.forbes.com\/sites\/larryhusten\/2014\/06\/13\/fda-advisory-panel-supports-novel-drug-coated-balloon\/\">recommended approval of the Lutonix DCB<\/a>\u00a0earlier this year. He noted that the panel wrestled with some difficult issues, including the apparent lack of benefit for women in the trial.\u00a0\u00a0But the panel voted unanimously to recommend approval, said Lange, in the belief that\u00a0the device was both safe and at least as effective as conventional therapy. \u201cIt\u2019s a little easier than a stent since you\u2019re not leaving anything inside,\u201d he said.<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The FDA today\u00a0announced\u00a0that it had approved\u00a0for use in the U.S. the first drug-coated angioplasty balloon catheter to re-open blocked arteries in the superficial femoral and popliteal arteries. The Lutonix 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (Lutonix DCB) is manufactured by\u00a0CR Bard\u00a0and has been available in\u00a0Europe\u00a0since 2012. &#8220;Peripheral artery disease can be quite serious. [&hellip;]<\/p>\n","protected":false},"author":196,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1,9,16],"tags":[2280,196,591,592],"class_list":["post-45567","post","type-post","status-publish","format-standard","hentry","category-general","category-interventional-cardiology","category-vascular","tag-drug-coated-balloon","tag-fda","tag-pad","tag-peripheral-artery-disease"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/45567","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=45567"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/45567\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=45567"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=45567"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=45567"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}