{"id":47058,"date":"2015-02-19T16:24:44","date_gmt":"2015-02-19T21:24:44","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=news&#038;p=47058"},"modified":"2015-02-19T16:24:44","modified_gmt":"2015-02-19T21:24:44","slug":"companies-plan-to-resume-renal-denervation-trials","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2015\/02\/19\/companies-plan-to-resume-renal-denervation-trials\/","title":{"rendered":"Companies Plan To Resume Renal Denervation Trials"},"content":{"rendered":"<p>Medtronic and Boston Scientific have announced plans to start phase 2 clinical trials this year for their updated renal denervation catheters. The once promising new technology is intended to treat hypertension unresponsive to drug therapy. The failure last year of Medtronic&#8217;s\u00a0<a title=\"No Benefit Found in First Real Test of Renal Denervation\" href=\"http:\/\/blogs.nejm.org\/cardioexchange\/news\/first-real-test-of-renal-denervation-shows-extremely-modest-treatment-effect\/\">Symplicity HTN-3<\/a>,\u00a0the first large\u00a0pivotal trial to rigorously test renal denervation, sent manufacturers back to their drawing boards to redesign the devices.<\/p>\n<p>Earlier this week Medtronic disclosed in its quarterly report that it planned to soon submit\u00a0to the FDA\u00a0its application for an investigational device exemption (IDE) for its next-generation renal denervation device. The spiral-shaped device has multiple electrodes and is designed to achieve more comprehensive ablation of the renal arteries. The company is seeking FDA approval to proceed with a phase II trial.<\/p>\n<p>In its quarterly report Boston Scientific said it plans to begin enrolling patients in the first half of this year in a phase II trial, called REDUCE-HTN REINFORCE, testing its Vessix platform. The company has not yet released details of the protocol but said the FDA has approved the protocol.<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Medtronic and Boston Scientific have announced plans to start phase 2 clinical trials this year for their updated renal denervation catheters. The once promising new technology is intended to treat hypertension unresponsive to drug therapy. The failure last year of Medtronic&#8217;s\u00a0Symplicity HTN-3,\u00a0the first large\u00a0pivotal trial to rigorously test renal denervation, sent manufacturers back to their [&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":[454,581,921],"class_list":["post-47058","post","type-post","status-publish","format-standard","hentry","category-interventional-cardiology","tag-hypertension","tag-renal-denervation","tag-resistant-hypertension"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/47058","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=47058"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/47058\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=47058"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=47058"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=47058"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}