{"id":39515,"date":"2013-10-23T11:40:34","date_gmt":"2013-10-23T15:40:34","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=news&#038;p=39515"},"modified":"2013-10-23T11:40:34","modified_gmt":"2013-10-23T15:40:34","slug":"fda-approves-first-new-atherectomy-device-in-20-years","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2013\/10\/23\/fda-approves-first-new-atherectomy-device-in-20-years\/","title":{"rendered":"FDA Approves First New Atherectomy Device in 20 Years"},"content":{"rendered":"<p>The FDA on Tuesday granted PMA approval to the Diamondback\u00a0360 Coronary Orbital Atherectomy System (OAS) for the treatment of severely calcified coronary arteries.\u00a0Cardiovascular Systems, the manufacturer of the device,\u00a0<a href=\"http:\/\/www.csi360newsroom.com\/newsrelease.aspx?p=1866696\">said<\/a>\u00a0that the OAS \u00a0was the first new coronary atherectomy system to receive FDA approval in two decades. The company said it would begin a controlled launch of the device immediately, focusing initially on &#8220;a limited number of the top medical institutions in the United States.&#8221;<\/p>\n<p>&#8220;Coronary calcium is undertreated in the cardiac cath lab. Having a user-friendly device available to effectively treat severe coronary calcium may increase the safety of CAD interventions for this difficult to treat population, while improving long-term patient prognoses,&#8221; said Gregg Stone, in a press release.<\/p>\n<p>The FDA approval was based on results of the\u00a0<a href=\"http:\/\/clinicaltrials.gov\/show\/NCT01092416\">ORBIT II study<\/a>, a prospective, single-arm, multicenter study that evaluated the safety and efficacy of the OAS system in patients\u00a0with severely calcified coronary lesions. The company said that it was &#8220;the first study in history that sought approval for treating these lesions.&#8221;\u00a0At 30 days, 89.8% of patients in the study were free of\u00a0major adverse cardiac events, the primary outcome of the study.<\/p>\n<p>Atherectomy, as cardiologists who have been around for a while will remember, has had a very long and torturous history in interventional cardiology. Although interventional cardiologists have been known for their ready adoption of new technology, it is unclear at this point how willing they will be to utilize a new atherectomy device.<\/p>\n<p><strong>Medtronic\u00a0Launches Aspiration Catheter<\/strong><\/p>\n<p>In separate news, Medtronic yesterday\u00a0<a href=\"http:\/\/newsroom.medtronic.com\/phoenix.zhtml?c=251324&amp;p=irol-newsArticle&amp;ID=1866269&amp;highlight=\">announced<\/a>\u00a0the launch of its\u00a0Export Advance aspiration catheter for coronary thrombus removal. The device was recently approved by the FDA. The company said the device\u00a0features a pre-loaded stylet that &#8220;increases the deliverability and kink resistance of the new device while traversing the vasculature to reach the aspiration site.&#8221;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The FDA on Tuesday granted PMA approval to the Diamondback\u00a0360 Coronary Orbital Atherectomy System (OAS) for the treatment of severely calcified coronary arteries.\u00a0Cardiovascular Systems, the manufacturer of the device,\u00a0said\u00a0that the OAS \u00a0was the first new coronary atherectomy system to receive FDA approval in two decades. The company said it would begin a controlled launch of [&hellip;]<\/p>\n","protected":false},"author":196,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[9],"tags":[609,222,1948],"class_list":["post-39515","post","type-post","status-publish","format-standard","hentry","category-interventional-cardiology","tag-atherectomy","tag-fda-approvals","tag-thrombus-aspiration"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/39515","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=39515"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/39515\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=39515"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=39515"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=39515"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}