{"id":545642,"date":"2026-07-12T08:46:19","date_gmt":"2026-07-12T08:46:19","guid":{"rendered":"https:\/\/www.newsbeep.com\/ie\/545642\/"},"modified":"2026-07-12T08:46:19","modified_gmt":"2026-07-12T08:46:19","slug":"jj-wins-fda-approval-for-dual-energy-ablation-catheter","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/ie\/545642\/","title":{"rendered":"J&#038;J wins FDA approval for dual-energy ablation catheter"},"content":{"rendered":"<p>        <img decoding=\"async\" class=\"text-to-speech__button__icon\" src=\"https:\/\/www.medtechdive.com\/static\/img\/play.svg?313321260226\" alt=\"\"\/><br \/>\n        Listen to the article<\/p>\n<p>            2 min<\/p>\n<p>            This audio is auto-generated. Please let us know if you have <a href=\"https:\/\/www.medtechdive.com\/contact\/\" rel=\"nofollow noopener\" target=\"_blank\">feedback<\/a>.<\/p>\n<p>Dive Brief:<\/p>\n<p>Johnson &amp; Johnson <a href=\"https:\/\/www.jnjmedtech.com\/en-US\/news\/press-releases\/johnson-johnson-announces-fda-approval-for-the-dual-energy-thermocool-smarttouch-sf-platform\/\" target=\"_blank\" rel=\"nofollow noopener\">has won<\/a> Food and Drug Administration approval for a catheter that delivers radiofrequency and pulsed field energy to treat atrial fibrillation.<br \/>\nThe approval, which J&amp;J disclosed Wednesday, covers the Dual Energy Thermocool Smarttouch SF Platform. J&amp;J already <a href=\"https:\/\/www.accessdata.fda.gov\/cdrh_docs\/pdf3\/P030031S100B.pdf\" target=\"_blank\" rel=\"nofollow noopener\">had approval<\/a> for a single, radiofrequency energy version of the device.<br \/>\nIntegrated into the company\u2019s Carto mapping system, the dual-energy catheter is part of J&amp;J\u2019s push to leverage its electrophysiology strength to reverse market share losses triggered by PFA.<\/p>\n<p>Dive Insight:<\/p>\n<p>Boston Scientific and Medtronic <a href=\"https:\/\/www.medtechdive.com\/news\/Johnson-JJ-FDA-approval-Varipulse-PFA\/732277\/\" target=\"_blank\" rel=\"nofollow noopener\">beat J&amp;J<\/a> to the PFA market. Shortly after J&amp;J launched its Varipulse PFA device, <a href=\"https:\/\/www.medtechdive.com\/news\/JNJ-Varipulse-US-pause\/736852\/\" target=\"_blank\" rel=\"nofollow noopener\">it <\/a><a href=\"https:\/\/www.medtechdive.com\/news\/JNJ-Varipulse-US-pause\/736852\/\" rel=\"nofollow noopener\" target=\"_blank\">temporarily<\/a><a href=\"https:\/\/www.medtechdive.com\/news\/JNJ-Varipulse-US-pause\/736852\/\" target=\"_blank\" rel=\"nofollow noopener\"> paused<\/a> all U.S. cases to investigate four reported neurovascular events.<\/p>\n<p>As 2026 began, J&amp;J CEO Joaquin Duato said the company was \u201cgaining back share in PFA\u201d and <a href=\"https:\/\/www.investor.jnj.com\/events-and-presentations\/events\/event-details\/2026\/Johnson-and-Johnson-Fourth-Quarter-2025-Earnings-Call-and-Webcast\/default.aspx\" target=\"_blank\" rel=\"nofollow noopener\">predicted that<\/a> it would launch \u201ca new catheter every year through the end of the decade.\u201d<\/p>\n<p>J&amp;J <a href=\"https:\/\/www.jnjmedtech.com\/en-US\/news\/press-releases\/johnson-johnson-medtech-announces-ce-mark-approval-for-dual-energy-thermocool-smarttouch-sf-catheter\/\" target=\"_blank\" rel=\"nofollow noopener\">received a CE mark<\/a> for the dual-energy Thermocool catheter in January 2025 and <a href=\"https:\/\/www.investor.jnj.com\/events-and-presentations\/events\/event-details\/2025\/Johnson--Johnson-Second-Quarter-2025-Earnings-Call-and-Webcast\/default.aspx\" target=\"_blank\" rel=\"nofollow noopener\">began its first cases<\/a> in Europe later that year. The company continues \u201cto receive strong feedback\u201d for the dual-energy device in Europe, <a href=\"https:\/\/www.investor.jnj.com\/events-and-presentations\/events\/event-details\/2026\/Johnson--Johnson-First-Quarter-2026-Earnings-Call\/default.aspx\" target=\"_blank\" rel=\"nofollow noopener\">Duato said<\/a> on J&amp;J\u2019s first-quarter earnings call in April.\u00a0<\/p>\n<p>Talking to J&amp;J\u2019s Michael Bodner at an event in May, RBC Capital Markets analyst <a href=\"https:\/\/www.investor.jnj.com\/events-and-presentations\/events\/event-details\/2026\/Johnson--Johnson-to-Participate-in-the-2026-RBC-Capital-Markets-Global-Healthcare-Conference\/default.aspx\" target=\"_blank\" rel=\"nofollow noopener\">Shagun Singh said<\/a> her channel checks indicated that dual-energy catheters are used in about 20% to 30% of cases. The device could help J&amp;J \u201cregain more share in the complicated end of the procedure spectrum,\u201d Singh said, citing key opinion leaders.<\/p>\n<p>Bodner, company group chair, electrophysiology and neurovascular at J&amp;J, said the dual-energy device is based on the most widely used radiofrequency catheter globally. The catheter is what physicians train on and are most used to, Bodner said.<\/p>\n<p>Adding the ability to toggle between radiofrequency and pulsed field energy gives physicians \u201ca lot of versatility, depending on the complexity of the patient,\u201d Bodner said. The J&amp;J executive outlined how ablations near anatomy such as the coronary arteries pose challenges that make access to different energy valuable.<\/p>\n","protected":false},"excerpt":{"rendered":"Listen to the article 2 min This audio is auto-generated. Please let us know if you have feedback.&hellip;\n","protected":false},"author":2,"featured_media":545643,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[34],"tags":[103,397,396,61,60],"class_list":["post-545642","post","type-post","status-publish","format-standard","has-post-thumbnail","category-healthcare","tag-health","tag-health-care","tag-healthcare","tag-ie","tag-ireland"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/posts\/545642","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/comments?post=545642"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/posts\/545642\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/media\/545643"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/media?parent=545642"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/categories?post=545642"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/tags?post=545642"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}