{"id":28589,"date":"2012-04-27T09:31:38","date_gmt":"2012-04-27T13:31:38","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=news&#038;p=28589"},"modified":"2012-04-27T09:31:38","modified_gmt":"2012-04-27T13:31:38","slug":"cameron-healths-subcutaneous-icd-sails-through-fda-advisory-panel","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2012\/04\/27\/cameron-healths-subcutaneous-icd-sails-through-fda-advisory-panel\/","title":{"rendered":"Cameron Health\u2019s Subcutaneous ICD Sails Through FDA Advisory Panel"},"content":{"rendered":"<p><a href=\"http:\/\/blogs.nejm.org\/cardioexchange\/wp-content\/uploads\/sites\/7\/2012\/04\/S-ICD1.jpg\"><img loading=\"lazy\" decoding=\"async\" class=\"alignleft size-full wp-image-28591\" title=\"S-ICD\" src=\"http:\/\/blogs.nejm.org\/cardioexchange\/wp-content\/uploads\/sites\/7\/2012\/04\/S-ICD1.jpg\" alt=\"\" width=\"167\" height=\"144\" \/><\/a>The FDA\u2019s Circulatory System Devices panel voted 7-1 on Thursday that the benefits of\u00a0the\u00a0<a href=\"http:\/\/www.cameronhealth.com\/\" target=\"_parent\">Cameron Health subcutaneous ICD system<\/a>\u00a0(S-ICD) outweigh the risks in appropriately selected patients.<\/p>\n<p>Unlike all previous ICDs, the S-ICD is much easier to implant because it is does not require threading a lead to connect the device to the heart. Panel member Rick Lange said the S-ICD was an example of \u201cI-should-have-thought-of-that technology\u201d, according to Heartwire reporter<a href=\"https:\/\/twitter.com\/#!\/reedheartwire\/status\/195608477387849728\" target=\"_parent\">\u00a0Reed Miller on Twitter<\/a>. That sentiment was echoed by device giant Boston Scientific in March when it agreed to acquire Cameron Health for $150 million initially, and as much as $1.2 billion in additional payments based on future performance, according to\u00a0<a href=\"http:\/\/www.reuters.com\/article\/2012\/03\/08\/bostonscientific-results-idUSL4E8E88LZ20120308\" target=\"_parent\">Reuters<\/a>.<\/p>\n<p>The advisory panel also voted 7-1 that the S-ICD was effective and 8-0 that it was safe.<\/p>\n<p>Earlier this week, FDA reviewers posted the previously unavailable\u00a0<a href=\"http:\/\/www.fda.gov\/downloads\/AdvisoryCommittees\/CommitteesMeetingMaterials\/MedicalDevices\/MedicalDevicesAdvisoryCommittee\/CirculatorySystemDevicesPanel\/UCM301228.pdf\" target=\"_parent\">results of the pivotal trial<\/a>\u00a0for the S-ICD. The FDA review set the tone for a generally supportive panel meeting, finding that the trial met its primary safety and efficacy endpoints, though it identified several potential safety issues.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The FDA\u2019s Circulatory System Devices panel voted 7-1 on Thursday that the benefits of\u00a0the\u00a0Cameron Health subcutaneous ICD system\u00a0(S-ICD) outweigh the risks in appropriately selected patients. Unlike all previous ICDs, the S-ICD is much easier to implant because it is does not require threading a lead to connect the device to the heart. Panel member Rick [&hellip;]<\/p>\n","protected":false},"author":196,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[1229,1238,448,1228],"class_list":["post-28589","post","type-post","status-publish","format-standard","hentry","category-electrophysiology","tag-cameron-health","tag-fda-advisory-panel","tag-icds","tag-subcutaneous-icd"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/28589","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=28589"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/28589\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=28589"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=28589"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=28589"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}