The FDA has granted marketing approval for the Thermocool Smarttouch ablation catheter for use in patients with drug-resistant paroxysmal atrial fibrillation (AF),\u00a0sustained monomorphic ischemic ventricular tachycardia, and type I atrial flutter. The device is\u00a0manufactured by Biosense Webster, a Johnson & Johnson company.<\/p>\n
The device, according to the company, “is the first therapeutic catheter approved in the U.S. that enables direct and real-time measurement of contact force during catheter ablation procedures.”<\/p>\n
The new catheter was evaluated in the SMART-AF Trial<\/a>, which was presented last May at the Heart Rhythm Society meeting (webcast of presentation<\/a>). At 1 year, there was a 74% overall success rate in patients treated with the catheter. There were, however, four cases of tamponade among the 160 patients who underwent ablation.<\/p>\n \u201cThe Thermcool Smarttouch catheter is an important new device that will benefit the electrophysiology community, as it will enable us to more precisely control the amount of contact force applied to the heart wall when creating lesions during catheter ablation,\u201d said Andrea Natale, the Primary Investigator of the trial, in a press release<\/a>. \u201cData from the SMART-AF Trial demonstrated that consistent and stable application of contact force has a significant impact on patient outcomes. The use of contact force-sensing technology has emerged as a critical tool in delivering optimal outcomes in the treatment of patients with atrial fibrillation and represents a major advancement for the clinical community.\u201d<\/p>\n <\/p>\n <\/p>\n","protected":false},"excerpt":{"rendered":" The FDA has granted marketing approval for the Thermocool Smarttouch ablation catheter for use in patients with drug-resistant paroxysmal atrial fibrillation (AF),\u00a0sustained monomorphic ischemic ventricular tachycardia, and type I atrial flutter. The device is\u00a0manufactured by Biosense Webster, a Johnson & Johnson company. The device, according to the company, “is the first therapeutic catheter approved in […]<\/p>\n","protected":false},"author":196,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13,9],"tags":[238,341,222,2183],"class_list":["post-41848","post","type-post","status-publish","format-standard","hentry","category-electrophysiology","category-interventional-cardiology","tag-ablation","tag-atrial-fibrillation","tag-fda-approvals","tag-tamponade"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/41848","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=41848"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/41848\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=41848"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=41848"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=41848"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}