{"id":1471,"date":"2010-03-16T15:02:00","date_gmt":"2010-03-16T19:02:00","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/tuesday-march-16-news-roundup-cryoballoon-ablation-trial-fda-to-review-accord-data-trouble-for-boston-scientific-and-medtronic\/"},"modified":"2011-07-19T17:45:00","modified_gmt":"2011-07-19T21:45:00","slug":"tuesday-march-16-news-roundup-cryoballoon-ablation-trial-fda-to-review-accord-data-trouble-for-boston-scientific-and-medtronic","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2010\/03\/16\/tuesday-march-16-news-roundup-cryoballoon-ablation-trial-fda-to-review-accord-data-trouble-for-boston-scientific-and-medtronic\/","title":{"rendered":"Tuesday, March 16 News Roundup: Cryoballoon Ablation Trial; FDA to Review ACCORD data; Trouble for Boston Scientific and Medtronic"},"content":{"rendered":"<p><strong>STOP-AF:<\/strong>\u00a0The STOP-AF trial compared a novel cryoballoon ablation technology\u00a0with antiarrhythmic drug (AAD) therapy in 245 AF patients who had failed at least one AAD. Treatment success was achieved in 69.9% of cryoballoon patients versus 7.3% of AAD patients, a highly significant difference (p&lt;0.001). Phrenic nerve palsy occurred in 13.5% of cryoballoon patients and 7.3% of AAD patients. <a href=\"http:\/\/www.cardiosource.com\/clinicaltrials\/trial.asp?trialID=1922\">The study was presented on Monday at the ACC.<\/a><br \/>\n<a href=\"http:\/\/www.cardiosource.com\/clinicaltrials\/trial.asp?trialID=1922\"><\/a><br \/>\n<a href=\"http:\/\/www.cardiosource.com\/clinicaltrials\/trial.asp?trialID=1922\"><\/a><strong>FDA to Review ACCORD Data:<\/strong>\u00a0Following the presentation and <a href=\"http:\/\/content.nejm.org\/cgi\/content\/full\/NEJMoa1001282\">publication in the<em> New England Journal of Medicine<\/em><\/a><em><\/em>\u00a0on Sunday of ACCORD, which found no benefit for fenofibrate when given on top of statins in patients with type 2 diabetes, the <a href=\"http:\/\/www.fda.gov\/Drugs\/DrugSafety\/PostmarketDrugSafetyInformationforPatientsandProviders\/ucm203681.htm\">FDA announced that it would review data from the trial<\/a>, but stated that &#8220;at this time, FDA has made no new conclusions or recommendations regarding the combination use of simvastatin or other statin drugs and fenofibrate.&#8221;<\/p>\n<p><strong>Boston Scientific Suspends ICD Sales:<\/strong> B<a href=\"http:\/\/bostonscientific.mediaroom.com\/index.php?s=43&amp;item=900\">oston Scientific announced on Monday<\/a> that it was suspending all sales of its ICDs and CRT-Ds. The suspension took place after the company &#8220;determined that some manufacturing process changes were not submitted for approval&#8221; to the FDA.<\/p>\n<p><strong>Medtronic Investigated by U.S. Attorney:<\/strong> In its most recent quarterly report, Medtronic disclosed that it was under investigation by the U.S. Attorney&#8217;s office in Massachusetts over the company&#8217;s relationship to cardiologists at the Lahey Clinic. (<a href=\"http:\/\/cardiobrief.org\/2010\/03\/15\/us-attorneys-office-investigating-medtronic-over-ties-to-lahey-clinic-cardiologists\/\">More details are available at CardioBrief<\/a>.)<\/p>\n","protected":false},"excerpt":{"rendered":"<p>STOP-AF:\u00a0The STOP-AF trial compared a novel cryoballoon ablation technology\u00a0with antiarrhythmic drug (AAD) therapy in 245 AF patients who had failed at least one AAD. Treatment success was achieved in 69.9% of cryoballoon patients versus 7.3% of AAD patients, a highly significant difference (p&lt;0.001). Phrenic nerve palsy occurred in 13.5% of cryoballoon patients and 7.3% of [&hellip;]<\/p>\n","protected":false},"author":196,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-1471","post","type-post","status-publish","format-standard","hentry","category-general"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/1471","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=1471"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/1471\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=1471"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=1471"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=1471"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}