{"id":46447,"date":"2015-01-05T16:05:10","date_gmt":"2015-01-05T21:05:10","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=news&#038;p=46447"},"modified":"2015-01-05T16:05:10","modified_gmt":"2015-01-05T21:05:10","slug":"fda-approves-new-drug-coated-balloon-to-open-blocked-leg-arteries","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2015\/01\/05\/fda-approves-new-drug-coated-balloon-to-open-blocked-leg-arteries\/","title":{"rendered":"FDA Approves New Drug-Coated Balloon to Open Blocked Leg Arteries"},"content":{"rendered":"<p>Medtronic\u00a0<a href=\"http:\/\/newsroom.medtronic.com\/phoenix.zhtml?c=251324&amp;p=irol-newsArticle&amp;ID=2002957\">said<\/a>\u00a0today that it had received approval from the FDA to market its IN.PACT Admiral drug-coated balloon (DCB) to treat peripheral artery disease (PAD) in the superficial femoral and popliteal arteries. The device is the second DCB to gain FDA approval. Last October\u00a0the FDA\u00a0<a href=\"http:\/\/www.forbes.com\/sites\/larryhusten\/2014\/10\/10\/first-drug-coated-balloon-approved-by-fda-for-leg-blockages\/\">approved<\/a>\u00a0CR Bard&#8217;s\u00a0Lutonix DCB for a similar indication.<\/p>\n<p>The new DCB uses\u00a0the anti-proliferative drug paclitaxel, which is designed to prevent renarrowing (restenosis) of the blood vessel after it is\u00a0opened by the expanded balloon. Approval of the device was based on the landmark\u00a0<a href=\"http:\/\/circ.ahajournals.org\/content\/early\/2014\/12\/03\/CIRCULATIONAHA.114.011004.abstract\">IN.PACT SFA trial published last month in\u00a0<em>Circulation<\/em>.<\/a>\u00a0Target\u00a0lesion revascularization was dramatically reduced in that trial from 20.6% in the group who received standard balloon angioplasty to 2.4% in the DCB group.\u00a0Medtronic\u00a0noted in its statement that approval had been granted without the use of an FDA advisory panel.<\/p>\n<p>The\u00a0IN.PACT Admiral DCB has been available in\u00a0Europe\u00a0since 2009.<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Medtronic\u00a0said\u00a0today that it had received approval from the FDA to market its IN.PACT Admiral drug-coated balloon (DCB) to treat peripheral artery disease (PAD) in the superficial femoral and popliteal arteries. The device is the second DCB to gain FDA approval. Last October\u00a0the FDA\u00a0approved\u00a0CR Bard&#8217;s\u00a0Lutonix DCB for a similar indication. The new DCB uses\u00a0the anti-proliferative drug [&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":[2459,196,1217,591,1017],"class_list":["post-46447","post","type-post","status-publish","format-standard","hentry","category-general","category-interventional-cardiology","category-vascular","tag-drug-coated-balloons","tag-fda","tag-medtronic","tag-pad","tag-peripheral-arterial-disease"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/46447","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=46447"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/46447\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=46447"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=46447"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=46447"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}