{"id":14507,"date":"2011-12-09T08:59:49","date_gmt":"2011-12-09T13:59:49","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=news&#038;p=14507"},"modified":"2011-12-09T08:59:49","modified_gmt":"2011-12-09T13:59:49","slug":"fda-advisory-panel-votes-against-implantable-cardiomems-hf-pressure-measurement-system","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2011\/12\/09\/fda-advisory-panel-votes-against-implantable-cardiomems-hf-pressure-measurement-system\/","title":{"rendered":"FDA Advisory Panel Votes Against Implantable CardioMEMS HF Pressure Measurement System"},"content":{"rendered":"<p>Members of the FDA Circulatory System Devices Panel on Thursday recommended against approval of the\u00a0implantable CardioMEMS HF Pressure Measurement System. Although panel members agreed that the device was safe by a 9-1 vote, they voted 7-3 that the device had not been shown to be effective and 6-4 that the benefits did not outweigh the risks.<\/p>\n<p>Panel discussion focused on\u00a0<a href=\"http:\/\/www.thelancet.com\/journals\/lancet\/article\/PIIS0140-6736(11)60101-3\/abstract\">the CHAMPION trial<\/a>. In an extraordinary addendum to its main review of the trial, the FDA reviewers raised serious concerns that &#8220;the conduct of the trial\u00a0may have biased the study results.&#8221; An audit of the trial by FDA inspectors determined that the sponsor or the principal investigators &#8220;routinely contacted investigational sites and made specific therapeutic recommendations for some Treatment Group study subjects.&#8221;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Members of the FDA Circulatory System Devices Panel on Thursday recommended against approval of the\u00a0implantable CardioMEMS HF Pressure Measurement System. Although panel members agreed that the device was safe by a 9-1 vote, they voted 7-3 that the device had not been shown to be effective and 6-4 that the benefits did not outweigh the [&hellip;]<\/p>\n","protected":false},"author":196,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[14],"tags":[1052,944,1065],"class_list":["post-14507","post","type-post","status-publish","format-standard","hentry","category-heart-failure","tag-cardiomems","tag-fda-advisory-committee","tag-implantable-monitors"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/14507","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=14507"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/14507\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=14507"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=14507"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=14507"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}