{"id":61154,"date":"2025-04-25T22:06:16","date_gmt":"2025-04-25T20:06:16","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/kardium-announces-1-year-pulsar-ide-study-results-for-its-pfa-device-the-globe-pf-system\/"},"modified":"2025-04-25T22:06:16","modified_gmt":"2025-04-25T20:06:16","slug":"kardium-announces-1-year-pulsar-ide-study-results-for-its-pfa-device-the-globe-pf-system","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/kardium-announces-1-year-pulsar-ide-study-results-for-its-pfa-device-the-globe-pf-system\/","title":{"rendered":"Kardium Announces 1-Year PULSAR IDE Study Results for Its PFA Device \u2013 the Globe\u00ae PF System"},"content":{"rendered":"<div>\n<p>VANCOUVER, British Columbia&#8211;(BUSINESS WIRE)&#8211;<a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fkardium.com%2F&amp;esheet=54243666&amp;newsitemid=20250425485422&amp;lan=en-US&amp;anchor=Kardium+Inc.&amp;index=1&amp;md5=f105e00f33116d870dbfa9e3ef505a35\" rel=\"nofollow\" shape=\"rect\">Kardium Inc.<\/a>, a private medical device company that\u2019s advancing the way the world treats atrial fibrillation (AF), announced late-breaking, one-year clinical trial results for its innovative pulsed field ablation (PFA) device\u2014the Globe PF System. These pivotal findings from the PULSAR IDE study were announced at the Heart Rhythm Society (HRS) meeting in San Diego<sup>1<\/sup>, highlighting the safety and efficacy data of the Globe PF System, which is currently under PMA review with the US FDA.\n<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20250425485422\/en\/801974\/5\/Kardium_Globe_array_deployed.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20250425485422\/en\/801974\/22\/Kardium_Globe_array_deployed.jpg\"><\/a><br \/><a href=\"https:\/\/mms.businesswire.com\/media\/20250425485422\/en\/801974\/5\/Kardium_Globe_array_deployed.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20250425485422\/en\/801974\/21\/Kardium_Globe_array_deployed.jpg\"><\/a><br \/><a href=\"https:\/\/mms.businesswire.com\/media\/20250425485422\/en\/801973\/5\/kardium_logo1.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20250425485422\/en\/801973\/22\/kardium_logo1.jpg\"><\/a><br \/><a href=\"https:\/\/mms.businesswire.com\/media\/20250425485422\/en\/801973\/5\/kardium_logo1.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20250425485422\/en\/801973\/21\/kardium_logo1.jpg\"><\/a><\/p>\n<p>\nKey results included:\n<\/p>\n<ul class=\"bwlistdisc\">\n<li>\n<b>0%<\/b> device-related primary safety events\n<\/li>\n<li>\n<b>78%<\/b> 12-month primary effectiveness\n<\/li>\n<li>\n<b>100%<\/b> acute procedural success\n<\/li>\n<li>\n<b>25-minute <\/b>average time to isolate all pulmonary veins\n<\/li>\n<li>\n<b>1.2 PFA applications<\/b> per vein<b> <\/b>on average\n<\/li>\n<\/ul>\n<p>\n&#8220;These impressive one\u2011year efficacy results underscore the advanced catheter design of the Globe PF System,\u201d said Dr. Vivek Reddy, Co-Principal Investigator from The Mount Sinai Fuster Heart Hospital, New York. \u201cGiven the excellent durability achieved by the Globe PF System, the efficacy result is likely approaching the limit of what we can achieve with PV isolation alone.\u201d\n<\/p>\n<p>\nWith just 1.2 applications per vein, the Globe PF System is the true single-shot PFA solution with integrated mapping and ablation built into a single catheter.\n<\/p>\n<p>\n\u201cWe are very pleased with the study&#8217;s safety results,\u201d says Dr. Atul Verma, Co-Principal Investigator from McGill University Health Centre in Montreal. \u201cThe Globe PF System has demonstrated an exceptional safety profile and offers many key safety differentiators. Its unique design provides single-shot energy application with precise ablation control that allows us to make individualized patient\u2011centered treatment decisions.&#8221;\n<\/p>\n<p>\nThe PULSAR IDE study is a global, prospective, multicenter, single-arm study to demonstrate the safety and long-term efficacy of the Globe PF System. The study enrolled 183 patients across 12 centers in the United States, Europe, and Canada with symptomatic paroxysmal atrial fibrillation. The data presented at HRS was preliminary and the full data will be included in a publication.\n<\/p>\n<p>\n\u201cThese are truly outstanding results from the PULSAR IDE study,\u201d said Kevin Chaplin, CEO of Kardium. \u201cThe Globe PF System achieved incredible results for safety, efficacy, durability, PFA applications and procedure times. This study is another big step towards achieving our mission at Kardium of delivering the best treatment for atrial fibrillation.\u201d\n<\/p>\n<p>\n<b>About the Globe PF System<\/b>\n<\/p>\n<p>\nAtrial fibrillation is the most common type of cardiac arrhythmia and affects more than 8 million people in the United States and nearly 50 million people worldwide.<sup>2<\/sup> Unlike other catheter ablation systems, the Globe PF System is the only solution of its kind to combine single-shot PV isolation, advanced mapping and atrial ablation into a single catheter.\n<\/p>\n<p>\n<b>About Kardium<\/b>\n<\/p>\n<p>\nWe are a rapidly growing, privately held medical solutions company made up of a team of scientists, engineers, creatives and business professionals. Our mission is to deliver the best treatment for atrial fibrillation.\n<\/p>\n<p>\nCAUTION &#8211; Investigational device. Limited by Federal (or United States) law to investigational use. This press release may contain forward-looking statements, which reflect current expectations regarding future events. These forward-looking statements involve risks and uncertainties that may cause actual results, performance or achievements to be materially different from those expressed or implied by such statements.\n<\/p>\n<table cellspacing=\"0\" class=\"bwtablemarginb bwblockalignl bwwidth100\">\n<tr>\n<td class=\"bwvertalignt bwwidth3\" colspan=\"1\" rowspan=\"1\">1.<\/td>\n<td class=\"bwvertalignt bwpadl0 bwwidth97\" colspan=\"1\" rowspan=\"1\">\n<p>\nA Multielectrode Spherical Array Pulsed Field Ablation System to Treat Paroxysmal Atrial Fibrillation: 1-Year Outcomes of the PULSAR IDE Trial. Oral presentation at HRS 2025 by Dr. Vivek Reddy (New York, USA).\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwwidth3\" colspan=\"1\" rowspan=\"1\">2.<\/td>\n<td class=\"bwvertalignt bwpadl0 bwwidth97\" colspan=\"1\" rowspan=\"1\">\n<p>\nKornej J, Benjamin EJ, Magnani JW. Atrial fibrillation: global burdens and global opportunities. Heart 2021;107:516-518.\n<\/p>\n<\/td>\n<\/tr>\n<\/table>\n<p>\n\u00a0\n<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\nT: +1.604.248.8891<br \/>\n<br \/>E: <a target=\"_blank\" href=\"&#x6d;a&#x69;&#108;&#x74;&#111;:&#x49;n&#x66;&#111;&#x40;&#107;a&#x72;&#100;&#x69;&#117;m&#x2e;c&#x6f;&#109;\" rel=\"nofollow\" shape=\"rect\">&#x49;&#x6e;&#x66;&#x6f;&#64;&#107;ard&#x69;&#x75;&#x6d;&#x2e;&#99;&#111;m<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>VANCOUVER, British Columbia&#8211;(BUSINESS WIRE)&#8211;Kardium Inc., a private medical device company that\u2019s advancing the way the world treats atrial fibrillation (AF), announced late-breaking, one-year clinical trial results for its innovative pulsed field ablation (PFA) device\u2014the Globe PF System. These pivotal findings from the PULSAR IDE study were announced at the Heart Rhythm Society (HRS) meeting in &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/kardium-announces-1-year-pulsar-ide-study-results-for-its-pfa-device-the-globe-pf-system\/\">[Read more&#8230;]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-61154","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Kardium Announces 1-Year PULSAR IDE Study Results for Its PFA Device \u2013 the Globe\u00ae PF System - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/kardium-announces-1-year-pulsar-ide-study-results-for-its-pfa-device-the-globe-pf-system\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Kardium Announces 1-Year PULSAR IDE Study Results for Its PFA Device \u2013 the Globe\u00ae PF System - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"VANCOUVER, British Columbia&#8211;(BUSINESS WIRE)&#8211;Kardium Inc., a private medical device company that\u2019s advancing the way the world treats atrial fibrillation (AF), announced late-breaking, one-year clinical trial results for its innovative pulsed field ablation (PFA) device\u2014the Globe PF System. 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