{"id":26668,"date":"2025-07-08T10:17:33","date_gmt":"2025-07-08T03:17:33","guid":{"rendered":"https:\/\/thaipropertynews.com\/feeds\/?p=26668"},"modified":"2025-07-08T10:17:33","modified_gmt":"2025-07-08T03:17:33","slug":"johnson-johnson-launches-varipulse-platform-across-asia-pacific-advancing-atrial-fibrillation-treatment","status":"publish","type":"post","link":"https:\/\/thaipropertynews.com\/feeds\/?p=26668","title":{"rendered":"Johnson &amp; Johnson Launches VARIPULSE\u2122 Platform across Asia-Pacific, Advancing Atrial Fibrillation Treatment"},"content":{"rendered":"<table border=\"0\" cellspacing=\"10\" cellpadding=\"5\" align=\"right\">\n<tbody>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mma.prnasia.com\/media2\/2554601\/Johnson_Johnson_MedTech_Logo.jpg?p=medium600\" border=\"0\" alt=\"\" title=\"logo\" hspace=\"0\" vspace=\"0\" width=\"118\" \/><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p class=\"prntac\"> <i>The VARIPULSE\u2122 Platform is the first Pulsed Field Ablation (PFA) system fully integrated with the CARTO\u2122 3 electroanatomical mapping system, designed to drive efficiency, reproducibility, and procedural accuracy.<sup>1,i,ii,iii,iv,v,vi,vii,viii,ix<\/sup><\/i> <\/p>\n<p class=\"prntac\"> <i>The VARIPULSE\u2122 Platform is approved in Japan, Hong Kong, China, Australia, Taiwan and Korea.<\/i> <\/p>\n<p> <span class=\"legendSpanClass\">IRVINE, Calif.<\/span>, <span class=\"legendSpanClass\">July 8, 2025<\/span> \/PRNewswire\/ &#8212;\u00a0Johnson &amp; Johnson MedTech, a global leader in cardiac arrhythmia treatment, today announced the launch of the VARIPULSE\u2122 Platform in Asia-Pacific. The platform is used to perform catheter ablation procedures for atrial fibrillation (AFib), an irregular and often rapid heartbeat caused by extra, uncoordinated electrical signals in the atria.<sup>x<\/sup> AFib is associated with structural changes in the heart due to underlying conditions and lifestyle factors.<sup>x<\/sup><sup>,xi<\/sup>\u00a0It significantly increases the risk of stroke, heart failure, and mortality.<\/p>\n<p>The VARIPULSE\u2122 Platform is the first PFA technology designed to streamline ablation and mapping through a single integrated workflow with the CARTO\u2122 3 System. This 3D electroanatomical cardiac mapping technology enables real-time visualization and supports precision, efficiency, reproducibility, and procedural accuracy for physicians treating patients with atrial fibrillation (AFib)<sup>xii<\/sup>. It enables safe and efficient<sup>i<\/sup><sup>,ii,iii,iv,v,vi,vii<\/sup>, patient-centric therapy with minimal to no fluoroscopy exposurex<sup>iii<\/sup><sup>,xiv,xv<\/sup>\u00a0and is compatible with deep and\/or conscious sedation.<sup>2,xvi,xvii<\/sup><\/p>\n<p>This innovation is backed by compelling clinical evidence. Both the <i>inspIRE<\/i> and <i>admIRE<\/i> clinical trials demonstrated strong safety and effectiveness of the VARIPULSE\u2122 Platform:<\/p>\n<ul type=\"disc\">\n<li>In\u00a0<i>inspIRE<\/i>, 80% of patients achieved freedom from recurrence with zero primary adverse events.<sup>xviii<\/sup><\/li>\n<li>In\u00a0<i>admIRE<\/i>, results showed a 75% overall primary effectiveness success rate<sup>3<\/sup>, a 2.9% primary adverse event rate<sup>4,xix<\/sup>, 100% of patients achieved acute procedural success<sup>5<\/sup>, 43% had same-day discharge, and 25% of procedures were performed without fluoroscopy<sup>6<\/sup>.<\/li>\n<li>In the ongoing\u00a0<i>VARIPURE<\/i> registry, which included first-time users, there were no serious adverse events and no complications linked to the platform, including zero neurovascular events or coronary spasms<sup>xx<\/sup>.<\/li>\n<\/ul>\n<p>&#8220;The introduction of the VARIPULSE\u2122 Platform in the Asia-Pacific region marks a significant advancement towards our goal of transforming atrial fibrillation care,&#8221; stated Jing Li, Vice President, Electrophysiology &amp; Neurovascular, Johnson &amp; Johnson MedTech, Asia Pacific. &#8220;The adoption of the VARIPULSE\u2122 Platform could demonstrate the unique value of integration with CARTO\u2122 3D to enhance efficiencies in the workflow of AFib treatment and improve patient outcomes.&#8221;<\/p>\n<p>Atrial Fibrillation affects over 16 million people in Asia-Pacific<sup>xxi<\/sup>. Symptoms and clinical consequences of AFib disrupt patient&#8217;s quality of life. The most common symptoms are heart palpitations, fatigue, shortness of breath, chest pain, and dizziness<sup>xxii<\/sup>. As a progressive condition, early intervention is critical to reducing the risk of stroke, heart failure, and cardiovascular mortality<sup>xxiii<\/sup>.<\/p>\n<p>Unlike traditional ablation methods that use heat or cold,\u00a0PFA uses short bursts of energy to affect heart tissue, potentially reducing the risk of damage to surrounding tissue such as the esophagus, pulmonary veins, and phrenic nerve.<\/p>\n<p>&#8220;PFA, as a new type of energy, has the potential to further enhance the safety and efficacy of catheter ablation treatment, which is desirable for patients&#8221; said Dr. Yasuo Okumura<sup>7<\/sup>, Professor and Department Head, Vice Hospital Director, Nihon University School of Medicine,\u00a0Itabashi Hospital, Tokyo, Japan. &#8220;PFA is a relatively new medical technology, and therefore it is important to continue to assess its effectiveness and efficacy in Asia while ensuring proper use. But so far, we know that the integration of PFA technology with 3D mapping enables physicians to review their procedure in detail, and this contributes to quality of healthcare for patients.&#8221;<\/p>\n<p> <b>About the VARIPULSE\u2122 Platform<br \/><\/b>The VARIPULSE\u2122 Platform is\u00a0Johnson &amp; Johnson\u00a0MedTech&#8217;s Pulsed Field ablation system. The fully integrated platform includes the VARIPULSE\u2122 Catheter, TRUPULSE\u2122 Generator, and CARTO\u2122 3 Mapping System\u00a0VARIPULSE\u2122 Software. The Platform is now approved for use in the United States, Europe, Asia Pacific, and Canada.<\/p>\n<p> <b>Cardiovascular Solutions from Johnson &amp; Johnson MedTech<br \/><\/b>Across Johnson &amp; Johnson, we are tackling the world&#8217;s most complex and pervasive health challenges. Through a cardiovascular portfolio that provides healthcare professionals with advanced mapping and navigation, miniaturized tech, and precise ablation we are addressing conditions with significant unmet needs such as heart failure, coronary artery disease, stroke, and atrial fibrillation. We are the global leaders in heart recovery, circulatory restoration, and the treatment of heart rhythm disorders, as well as an emerging leader in neurovascular care, committed to taking on two of the leading causes of death worldwide in heart failure and stroke. For more, visit <a href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=4463762-1&amp;h=209699469&amp;u=https%3A%2F%2Fbiosensewebster.com%2F&amp;a=biosensewebster.com\" target=\"_blank\" rel=\"nofollow\">biosensewebster.com<\/a>.<\/p>\n<p> <b>About Johnson &amp; Johnson<br \/><\/b>At Johnson &amp; Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more about our MedTech sector&#8217;s global scale and deep expertise in surgery, orthopaedics, vision, and cardiovascular solutions at <a href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=4463762-1&amp;h=3654169690&amp;u=https%3A%2F%2Fthenext.jnjmedtech.com%2F&amp;a=https%3A%2F%2Fthenext.jnjmedtech.com%2F\" target=\"_blank\" rel=\"nofollow\">https:\/\/thenext.jnjmedtech.com\/<\/a>. Follow us at <a href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=4463762-1&amp;h=2760173889&amp;u=https%3A%2F%2Fx.com%2FJNJMedTech&amp;a=%40JNJMedTech\" target=\"_blank\" rel=\"nofollow\">@JNJMedTech<\/a>\u00a0and on <a href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=4463762-1&amp;h=3538860342&amp;u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fjohnson-%26-johnson-medtech&amp;a=LinkedIn\" target=\"_blank\" rel=\"nofollow\">LinkedIn<\/a>. Biosense Webster, Inc. is a Johnson &amp; Johnson MedTech company.<\/p>\n<p> <b>Cautions Concerning Forward-Looking Statements:\u00a0<\/b>This press release contains &#8220;forward-looking statements&#8221; as defined in the Private Securities Litigation Reform Act of 1995 regarding the VARIPULSE\u2122 Platform. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson &amp; Johnson. Risks and uncertainties include, but are not limited to: uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; manufacturing difficulties and delays; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of health care products and services; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson &amp; Johnson&#8217;s most recent Annual Report on Form 10-K, including in the sections captioned &#8220;Cautionary Note Regarding Forward-Looking Statements&#8221; and &#8220;Item 1A. Risk Factors,&#8221; and in Johnson &amp; Johnson&#8217;s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at <a href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=4463762-1&amp;h=886279743&amp;u=https%3A%2F%2Fwww.sec.gov%2F&amp;a=www.sec.gov\" target=\"_blank\" rel=\"nofollow\">www.sec.gov<\/a>, <a href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=4463762-1&amp;h=338247945&amp;u=https%3A%2F%2Fwww.jnj.com%2F&amp;a=www.jnj.com\" target=\"_blank\" rel=\"nofollow\">www.jnj.com<\/a>\u00a0or on request from Johnson &amp; Johnson. Johnson &amp; Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.\u00a0<\/p>\n<p>\u00a9 Johnson &amp; Johnson and its affiliates 2025. All rights reserved. M_US_ELP_NAVI_403012<\/p>\n<div>\n<table border=\"0\" cellspacing=\"0\" cellpadding=\"1\" class=\"prnbcc\">\n<tbody>\n<tr>\n<td class=\"prngen2\" colspan=\"2\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">________________________________________<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>1<\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">When compared to procedures that did not use navigation systems.<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>2<\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">Based on a subset of 29 deep sedation patients from the\u00a0inspIRE study and 60 patients in inspIRE study. Procedures completed under sedation vs general anesthesia had comparable safety rates and procedure times, demonstrating safety and procedural efficiency.<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>3<\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">Primary effectiveness was defined as 12-month freedom from documented (symptomatic or asymptomatic) atrial tachyarrhythmia (atrial fibrillation [AF]\/atrial tachycardia [AT]\/atrial flutter [AF]) episodes of \u226530 seconds duration based on rhythm monitoring during the post-blanking evaluation period (day 91-365), as well as freedom from other failure modes: failure to achieve entrance block in all PVs; &gt;1 repeat ablation for atrial tachyarrhythmia during the 3-month blanking period or any repeat ablation during the evaluation period; use of a nonstudy catheter to treat the PVs and\/or to ablate left atrial non-PV AF targets during the index procedure or to perform a repeat procedure during the 3-month blanking period; taking new or previously failed Class I\/III AADs at greater doses during the evaluation period; continuous AF\/AT\/AFL of unknown origin during the evaluation period; or direct-current cardioversion during the evaluation period for AF\/AT\/AFL recurrences. The protocol defined performance goal is 50%.<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>4<\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">Primary adverse events included device- or procedure- related death, major vascular access complications or bleeding, myocardial infarction,\u00a0pericarditis, heart block, permanent phrenic nerve paralysis, stroke, thromboembolism, transient ischemic attack, pulmonary edema, and vagal nerve injury\/gastroparesis within 7 days of the index ablation procedure. PAEs also included cardiac tamponade\/perforation occurring up to 30 days post-procedure, atrioesophageal fistula occurring up to 90 days postprocedure, and PV stenosis occurring anytime during the 12-month follow-up period. The protocol-defined performance goal was 12%.<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>5<\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">Acute procedural success was defined as the percent of participants with electrical isolation of all PVs with confirmed entrance block at the end of the procedure (n=255).<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>6<\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">Visualization performed with ICE and the\u00a0CARTO\u2122 3 System.<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>7<\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">Dr.\u00a0Okumura serves as a consultant for Johnson &amp; Johnson but was not compensated for this announcement<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"2\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">________________________________________<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>i<\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">Duytschaever M, De Potter T, Grimaldi M, et al. Paroxysmal Atrial Fibrillation Ablation Using a Novel Variable-Loop Biphasic Pulsed Field Ablation Catheter Integrated With a 3-Dimensional Mapping System: 1-Year Outcomes of the Multicenter inspIRE Study. Circ Arrhythm Electrophysiol. 2023;16(3):e011780. doi:10.1161\/CIRCEP.122.011780 pg 4<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>ii <\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">Reddy VY, Calkins H, Mansour M, Wazni O, Di Biase L, Bahu M, Newton D, Liu CF, Sauer WH, Goyal S, Iyer V, Nair D, Athill C, Hussein A, Whalen P, Melby D, Natale A; AdmIRE Trial Investigators. Pulsed Field Ablation to Treat Paroxysmal Atrial Fibrillation: Safety and Effectiveness in the AdmIRE Pivotal Trial. Circulation. 2024 Oct 8 pg 8<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>iii <\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">Anter, E., Mansour, M., Nair, D.G. et al. Dual-energy lattice-tip ablation system for persistent atrial fibrillation: a randomized trial. Nat Med 30, 2303\u20132310 (2024). https:\/\/doi.org\/10.1038\/s41591-024-03022-6 pg 2<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>iv <\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">Reddy VY, Lehmann JW, Gerstenfeld EP, Mugglin AS, Schneider CW, Achyutha AB, Mansour M. A randomized controlled trial of pulsed field ablation versus standard-of-care ablation for paroxysmal atrial fibrillation: The ADVENT trial rationale and design. Heart Rhythm O2. 2023 Mar 8;4(5):317-328. doi: 10.1016\/j.hroo.2023.03.001. PMID: 37323994; PMCID: PMC10264259. Pg 6<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>v <\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">VOLT\u00a0CE Mark Study: Long-term safety and effectiveness of de novo PVI intreating AF. pg 3<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>vi <\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">Scherr D, Turagam MK, Maury P, Blaauw Y, van der Voort P, Neuzil P, et al. Repeat procedures after pulsed field ablation for atrial fibrillation: MANIFEST-REDO study. Europace. 2025;2025(1):euaf012. doi:10.1093\/europace\/euaf012. Pg 4 results section<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>vii <\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">Seemala SKR, Musikantow DR, Perdomo C, Malyshev Y, Ambesh P, Saleem M, et al. Pulsed field ablation (PFA) to treat atrial fibrillation and related arrhythmias: one-year outcomes of the VIRTUE trial. Poster PO-FP-006. Pg 1<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>viii <\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">Fink T, Sciacca V, Bannmann K, et al. First experience using a novel variable loop catheter for mapping and pulsed field ablation of atrial fibrillation. Pacing Clin Electrophysiol. 2025 May;48(5):471-479. doi:10.1111\/pace.15177. Epub 2025 Mar 28. PMID:40153431; PMCID:PMC12063197<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>ix <\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">Fink T, Sciacca V, Bannmann K, et al. First experience using a novel variable loop catheter for mapping and pulsed field ablation of atrial fibrillation. Pacing Clin Electrophysiol. 2025 Mar 28. doi:10.1111\/pace.15177. Epub ahead of print. PMID: 40153431.<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>x <\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">Laizzo PA. Handbook of Cardiac Anatomy, Physiology, and Devices. 2015. Springer Science+Business Media. LLC: Switzerland<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>xi <\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">Staerk L, Sherer JA, Ko D, Benjamin EJ, Helm RH. Atrial Fibrillation: Epidemiology, Pathophysiology, and Clinical Outcomes. Circ Res. 2017;120(9):1501-1517<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>xii <\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">Di Biase L, Zou F, Lin AN, et al.\u00a0Feasibility of Three-Dimensional Artificial Intelligence Algorithm Integration with Intracardiac Echocardiography for\u00a0Left Atrial Imaging During Atrial Fibrillation Catheter Ablation. Europace. 2023 Aug 2;25(9):euad211.<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>xiii <\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">Debreceni D, Janosi K, Bocz B, et al. (2023). Zero fluoroscopy catheter ablation for atrial fibrillation: a systematic review and meta-analysis. Front Cardiovasc Med;10:1178783. doi: 10.3389\/fcvm.2023.1178783<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>xiv <\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">Rajendra A, Hunter TD, Morales GX, et al. (2023). Steerable sheath visualizable under 3D electroanatomical mapping facilitates paroxysmal atrial\u00a0fibrillation ablation with minimal fluoroscopy. J Interv Card Electrophysiol;66(2):381-388. doi: 10.1007\/s10840-022-01332-8.<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>xv <\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">Tahin T, Riba A, Nemeth B, et al. (2021). Implementation of a zero fluoroscopic workflow using a simplified intracardiac echocardiography guided method for catheter ablation of atrial fibrillation, including repeat procedures. BMC Cardiovasc Disord;21(1):407. doi: 10.1186\/s12872-021-02219-8.<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>xvi <\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">Grimaldi M, Quadrini F, Caporusso N, et al. Deep sedation protocol during atrial fibrillation ablation using a novel variable-loop biphasic pulsed field ablation catheter. Europace. 2023;25(9):euad222. doi:10.1093\/europace\/euad222. PMID: 37470452; PMCID: PMC10434733.<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>xvii<\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">De Potter T,\u00a0Grimaldi M, Duytschaever M, Anic A, Vijgen J, Neuzil P, Van Herendael H, Verma A, Skanes A, Scherr D, P\u00fcrerfellner H, Rackauskas G, Jais P, Reddy VY, et al; inspIRE Trial Investigators. Predictors of success for pulmonary vein isolation with pulsed-field ablation using a variable-loop catheter with 3D mapping integration: complete 12-month outcomes from inspIRE. Circ Arrhythm Electrophysiol. 2024;17(5):e012667. doi:10.1161\/CIRCEP.123.012667. Epub 2024 Apr 24. PMID: 38655693; PMCID: PMC11111320.<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>xviii <\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">Reddy V, Grimaldi M, Duytschaever M, Anic A. Predictors of Success for Pulmonary Vein Isolation with Pulsed Field Ablation Using a Variable Loop Catheter with 3D Mapping Integration: Complete 12-month outcomes from inspIRE [abstract]. In: AF Symposium.; February 2-4; Boston.<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>xix <\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">Reddy V, Calkins H, Mansour M, et al.\u00a0<a href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=4463762-1&amp;h=4157243364&amp;u=https%3A%2F%2Fwww.ahajournals.org%2Fdoi%2Fabs%2F10.1161%2FCIRCULATIONAHA.124.070333&amp;a=Pulsed+field+ablation+to+treat+paroxysmal+atrial+fibrillation%3A+safety+and+effectiveness+in+the+admIRE+pivotal+trial\" target=\"_blank\" class=\"prnews_a\" rel=\"nofollow\">Pulsed field ablation to treat paroxysmal atrial fibrillation: safety and effectiveness in the admIRE pivotal trial<\/a>. Circulation. Published online September 11, 2024. doi: 10.1161\/CIRCULATIONAHA.124.070333.<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>xx <\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">Bessi\u00e8re F, Kronborg MB, Sommer P, et al. Evaluating Safety Profile and Learning Curve With a Pulsed Field Ablation Variable Loop Circular Catheter in Procedures for AF: Observations From a Prospective, Multicenter, Postmarket Clinical Trial. Presented at HRS 2025; April 27, 2025; San Diego, CA.<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>xxi <\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">Global Burden of Disease Collaborative Network (2017) Global Burden of Disease Study 2017 (GBD 2017) Results. Seattle, United States: Institute for Health Metrics and Evaluation (IHME), 2017. Accessed 2019-07-16. Available from http:\/\/ghdx.healthdata.org\/gbd-results-tool.<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>xxii <\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">American Heart Association . (2024, August 12).\u00a0<i>What are the symptoms of atrial fibrillation?<\/i>. www.heart.org. https:\/\/www.heart.org\/en\/health-topics\/atrial-fibrillation\/what-are-the-symptoms-of-atrial-fibrillation-afib-or-af<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>xxiii <\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">Joglar JA, Chung MK, Armbruster AL, et al. 2023 ACC\/AHA\/ACCP\/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation: A Report of the American College of Cardiology\/American Heart Association Joint Committee on Clinical Practice Guidelines [published correction appears in Circulation. 2024 Jan 2;149(1):e167]. Circulation. 2024;149(1):e1-e156. doi:10.1161\/CIR.0000000000001193<\/span> <\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table><\/div>\n<p> <b>Media contacts:<\/b> <br \/>Carlos Taveras <br \/><a href=\"mailto:Ctaveras@its.jnj.com\" target=\"_blank\" rel=\"nofollow\">Ctaveras@its.jnj.com<\/a><br \/>Erin Farley<br \/><a href=\"mailto:Efarley1@its.jnj.com\" target=\"_blank\" rel=\"nofollow\">Efarley1@its.jnj.com<\/a>\u00a0<\/p>","protected":false},"excerpt":{"rendered":"<p><!-- wp:html --><\/p>\n<table border=\"0\" cellspacing=\"10\" cellpadding=\"5\" align=\"right\">\n<tbody>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mma.prnasia.com\/media2\/2554601\/Johnson_Johnson_MedTech_Logo.jpg?p=medium600\" border=\"0\" alt=\"\" title=\"logo\" hspace=\"0\" vspace=\"0\" width=\"118\" \/><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p class=\"prntac\"> <i>The VARIPULSE\u2122 Platform is the first Pulsed Field Ablation (PFA) system fully integrated with the CARTO\u2122 3 electroanatomical mapping system, designed to drive efficiency, reproducibility, and procedural accuracy.<sup>1,i,ii,iii,iv,v,vi,vii,viii,ix<\/sup><\/i> <\/p>\n<p class=\"prntac\"> <i>The VARIPULSE\u2122 Platform is approved in Japan, Hong Kong, China, Australia, Taiwan and Korea.<\/i> <\/p>\n<p> <span class=\"legendSpanClass\">IRVINE, Calif.<\/span>, <span class=\"legendSpanClass\">July 8, 2025<\/span> \/PRNewswire\/ &#8212;\u00a0Johnson &amp; Johnson MedTech, a global leader in cardiac arrhythmia treatment, today announced the launch of the VARIPULSE\u2122 Platform in Asia-Pacific. The platform is used to perform catheter ablation procedures for atrial fibrillation (AFib), an irregular and often rapid heartbeat caused by extra, uncoordinated electrical signals in the atria.<sup>x<\/sup> AFib is associated with structural changes in the heart due to underlying conditions and lifestyle factors.<sup>x<\/sup><sup>,xi<\/sup>\u00a0It significantly increases the risk of stroke, heart failure, and mortality.<\/p>\n<p>The VARIPULSE\u2122 Platform is the first PFA technology designed to streamline ablation and mapping through a single integrated workflow with the CARTO\u2122 3 System. This 3D electroanatomical cardiac mapping technology enables real-time visualization and supports precision, efficiency, reproducibility, and procedural accuracy for physicians treating patients with atrial fibrillation (AFib)<sup>xii<\/sup>. It enables safe and efficient<sup>i<\/sup><sup>,ii,iii,iv,v,vi,vii<\/sup>, patient-centric therapy with minimal to no fluoroscopy exposurex<sup>iii<\/sup><sup>,xiv,xv<\/sup>\u00a0and is compatible with deep and\/or conscious sedation.<sup>2,xvi,xvii<\/sup><\/p>\n<p>This innovation is backed by compelling clinical evidence. Both the <i>inspIRE<\/i> and <i>admIRE<\/i> clinical trials demonstrated strong safety and effectiveness of the VARIPULSE\u2122 Platform:<\/p>\n<ul type=\"disc\">\n<li>In\u00a0<i>inspIRE<\/i>, 80% of patients achieved freedom from recurrence with zero primary adverse events.<sup>xviii<\/sup><\/li>\n<li>In\u00a0<i>admIRE<\/i>, results showed a 75% overall primary effectiveness success rate<sup>3<\/sup>, a 2.9% primary adverse event rate<sup>4,xix<\/sup>, 100% of patients achieved acute procedural success<sup>5<\/sup>, 43% had same-day discharge, and 25% of procedures were performed without fluoroscopy<sup>6<\/sup>.<\/li>\n<li>In the ongoing\u00a0<i>VARIPURE<\/i> registry, which included first-time users, there were no serious adverse events and no complications linked to the platform, including zero neurovascular events or coronary spasms<sup>xx<\/sup>.<\/li>\n<\/ul>\n<p>&#8220;The introduction of the VARIPULSE\u2122 Platform in the Asia-Pacific region marks a significant advancement towards our goal of transforming atrial fibrillation care,&#8221; stated Jing Li, Vice President, Electrophysiology &amp; Neurovascular, Johnson &amp; Johnson MedTech, Asia Pacific. &#8220;The adoption of the VARIPULSE\u2122 Platform could demonstrate the unique value of integration with CARTO\u2122 3D to enhance efficiencies in the workflow of AFib treatment and improve patient outcomes.&#8221;<\/p>\n<p>Atrial Fibrillation affects over 16 million people in Asia-Pacific<sup>xxi<\/sup>. Symptoms and clinical consequences of AFib disrupt patient&#8217;s quality of life. The most common symptoms are heart palpitations, fatigue, shortness of breath, chest pain, and dizziness<sup>xxii<\/sup>. As a progressive condition, early intervention is critical to reducing the risk of stroke, heart failure, and cardiovascular mortality<sup>xxiii<\/sup>.<\/p>\n<p>Unlike traditional ablation methods that use heat or cold,\u00a0PFA uses short bursts of energy to affect heart tissue, potentially reducing the risk of damage to surrounding tissue such as the esophagus, pulmonary veins, and phrenic nerve.<\/p>\n<p>&#8220;PFA, as a new type of energy, has the potential to further enhance the safety and efficacy of catheter ablation treatment, which is desirable for patients&#8221; said Dr. Yasuo Okumura<sup>7<\/sup>, Professor and Department Head, Vice Hospital Director, Nihon University School of Medicine,\u00a0Itabashi Hospital, Tokyo, Japan. &#8220;PFA is a relatively new medical technology, and therefore it is important to continue to assess its effectiveness and efficacy in Asia while ensuring proper use. But so far, we know that the integration of PFA technology with 3D mapping enables physicians to review their procedure in detail, and this contributes to quality of healthcare for patients.&#8221;<\/p>\n<p> <b>About the VARIPULSE\u2122 Platform<br \/><\/b>The VARIPULSE\u2122 Platform is\u00a0Johnson &amp; Johnson\u00a0MedTech&#8217;s Pulsed Field ablation system. The fully integrated platform includes the VARIPULSE\u2122 Catheter, TRUPULSE\u2122 Generator, and CARTO\u2122 3 Mapping System\u00a0VARIPULSE\u2122 Software. The Platform is now approved for use in the United States, Europe, Asia Pacific, and Canada.<\/p>\n<p> <b>Cardiovascular Solutions from Johnson &amp; Johnson MedTech<br \/><\/b>Across Johnson &amp; Johnson, we are tackling the world&#8217;s most complex and pervasive health challenges. Through a cardiovascular portfolio that provides healthcare professionals with advanced mapping and navigation, miniaturized tech, and precise ablation we are addressing conditions with significant unmet needs such as heart failure, coronary artery disease, stroke, and atrial fibrillation. We are the global leaders in heart recovery, circulatory restoration, and the treatment of heart rhythm disorders, as well as an emerging leader in neurovascular care, committed to taking on two of the leading causes of death worldwide in heart failure and stroke. For more, visit <a href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=4463762-1&amp;h=209699469&amp;u=https%3A%2F%2Fbiosensewebster.com%2F&amp;a=biosensewebster.com\" target=\"_blank\" rel=\"nofollow\">biosensewebster.com<\/a>.<\/p>\n<p> <b>About Johnson &amp; Johnson<br \/><\/b>At Johnson &amp; Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more about our MedTech sector&#8217;s global scale and deep expertise in surgery, orthopaedics, vision, and cardiovascular solutions at <a href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=4463762-1&amp;h=3654169690&amp;u=https%3A%2F%2Fthenext.jnjmedtech.com%2F&amp;a=https%3A%2F%2Fthenext.jnjmedtech.com%2F\" target=\"_blank\" rel=\"nofollow\">https:\/\/thenext.jnjmedtech.com\/<\/a>. Follow us at <a href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=4463762-1&amp;h=2760173889&amp;u=https%3A%2F%2Fx.com%2FJNJMedTech&amp;a=%40JNJMedTech\" target=\"_blank\" rel=\"nofollow\">@JNJMedTech<\/a>\u00a0and on <a href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=4463762-1&amp;h=3538860342&amp;u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fjohnson-%26-johnson-medtech&amp;a=LinkedIn\" target=\"_blank\" rel=\"nofollow\">LinkedIn<\/a>. Biosense Webster, Inc. is a Johnson &amp; Johnson MedTech company.<\/p>\n<p> <b>Cautions Concerning Forward-Looking Statements:\u00a0<\/b>This press release contains &#8220;forward-looking statements&#8221; as defined in the Private Securities Litigation Reform Act of 1995 regarding the VARIPULSE\u2122 Platform. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson &amp; Johnson. Risks and uncertainties include, but are not limited to: uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; manufacturing difficulties and delays; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of health care products and services; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson &amp; Johnson&#8217;s most recent Annual Report on Form 10-K, including in the sections captioned &#8220;Cautionary Note Regarding Forward-Looking Statements&#8221; and &#8220;Item 1A. Risk Factors,&#8221; and in Johnson &amp; Johnson&#8217;s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at <a href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=4463762-1&amp;h=886279743&amp;u=https%3A%2F%2Fwww.sec.gov%2F&amp;a=www.sec.gov\" target=\"_blank\" rel=\"nofollow\">www.sec.gov<\/a>, <a href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=4463762-1&amp;h=338247945&amp;u=https%3A%2F%2Fwww.jnj.com%2F&amp;a=www.jnj.com\" target=\"_blank\" rel=\"nofollow\">www.jnj.com<\/a>\u00a0or on request from Johnson &amp; Johnson. Johnson &amp; Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.\u00a0<\/p>\n<p>\u00a9 Johnson &amp; Johnson and its affiliates 2025. All rights reserved. M_US_ELP_NAVI_403012<\/p>\n<div>\n<table border=\"0\" cellspacing=\"0\" cellpadding=\"1\" class=\"prnbcc\">\n<tbody>\n<tr>\n<td class=\"prngen2\" colspan=\"2\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">________________________________________<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>1<\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">When compared to procedures that did not use navigation systems.<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>2<\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">Based on a subset of 29 deep sedation patients from the\u00a0inspIRE study and 60 patients in inspIRE study. Procedures completed under sedation vs general anesthesia had comparable safety rates and procedure times, demonstrating safety and procedural efficiency.<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>3<\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">Primary effectiveness was defined as 12-month freedom from documented (symptomatic or asymptomatic) atrial tachyarrhythmia (atrial fibrillation [AF]\/atrial tachycardia [AT]\/atrial flutter [AF]) episodes of \u226530 seconds duration based on rhythm monitoring during the post-blanking evaluation period (day 91-365), as well as freedom from other failure modes: failure to achieve entrance block in all PVs; &gt;1 repeat ablation for atrial tachyarrhythmia during the 3-month blanking period or any repeat ablation during the evaluation period; use of a nonstudy catheter to treat the PVs and\/or to ablate left atrial non-PV AF targets during the index procedure or to perform a repeat procedure during the 3-month blanking period; taking new or previously failed Class I\/III AADs at greater doses during the evaluation period; continuous AF\/AT\/AFL of unknown origin during the evaluation period; or direct-current cardioversion during the evaluation period for AF\/AT\/AFL recurrences. The protocol defined performance goal is 50%.<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>4<\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">Primary adverse events included device- or procedure- related death, major vascular access complications or bleeding, myocardial infarction,\u00a0pericarditis, heart block, permanent phrenic nerve paralysis, stroke, thromboembolism, transient ischemic attack, pulmonary edema, and vagal nerve injury\/gastroparesis within 7 days of the index ablation procedure. PAEs also included cardiac tamponade\/perforation occurring up to 30 days post-procedure, atrioesophageal fistula occurring up to 90 days postprocedure, and PV stenosis occurring anytime during the 12-month follow-up period. The protocol-defined performance goal was 12%.<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>5<\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">Acute procedural success was defined as the percent of participants with electrical isolation of all PVs with confirmed entrance block at the end of the procedure (n=255).<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>6<\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">Visualization performed with ICE and the\u00a0CARTO\u2122 3 System.<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>7<\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">Dr.\u00a0Okumura serves as a consultant for Johnson &amp; Johnson but was not compensated for this announcement<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"2\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">________________________________________<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>i<\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">Duytschaever M, De Potter T, Grimaldi M, et al. Paroxysmal Atrial Fibrillation Ablation Using a Novel Variable-Loop Biphasic Pulsed Field Ablation Catheter Integrated With a 3-Dimensional Mapping System: 1-Year Outcomes of the Multicenter inspIRE Study. Circ Arrhythm Electrophysiol. 2023;16(3):e011780. doi:10.1161\/CIRCEP.122.011780 pg 4<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>ii <\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">Reddy VY, Calkins H, Mansour M, Wazni O, Di Biase L, Bahu M, Newton D, Liu CF, Sauer WH, Goyal S, Iyer V, Nair D, Athill C, Hussein A, Whalen P, Melby D, Natale A; AdmIRE Trial Investigators. Pulsed Field Ablation to Treat Paroxysmal Atrial Fibrillation: Safety and Effectiveness in the AdmIRE Pivotal Trial. Circulation. 2024 Oct 8 pg 8<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>iii <\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">Anter, E., Mansour, M., Nair, D.G. et al. Dual-energy lattice-tip ablation system for persistent atrial fibrillation: a randomized trial. Nat Med 30, 2303\u20132310 (2024). https:\/\/doi.org\/10.1038\/s41591-024-03022-6 pg 2<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>iv <\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">Reddy VY, Lehmann JW, Gerstenfeld EP, Mugglin AS, Schneider CW, Achyutha AB, Mansour M. A randomized controlled trial of pulsed field ablation versus standard-of-care ablation for paroxysmal atrial fibrillation: The ADVENT trial rationale and design. Heart Rhythm O2. 2023 Mar 8;4(5):317-328. doi: 10.1016\/j.hroo.2023.03.001. PMID: 37323994; PMCID: PMC10264259. Pg 6<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>v <\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">VOLT\u00a0CE Mark Study: Long-term safety and effectiveness of de novo PVI intreating AF. pg 3<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>vi <\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">Scherr D, Turagam MK, Maury P, Blaauw Y, van der Voort P, Neuzil P, et al. Repeat procedures after pulsed field ablation for atrial fibrillation: MANIFEST-REDO study. Europace. 2025;2025(1):euaf012. doi:10.1093\/europace\/euaf012. Pg 4 results section<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>vii <\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">Seemala SKR, Musikantow DR, Perdomo C, Malyshev Y, Ambesh P, Saleem M, et al. Pulsed field ablation (PFA) to treat atrial fibrillation and related arrhythmias: one-year outcomes of the VIRTUE trial. Poster PO-FP-006. Pg 1<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>viii <\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">Fink T, Sciacca V, Bannmann K, et al. First experience using a novel variable loop catheter for mapping and pulsed field ablation of atrial fibrillation. Pacing Clin Electrophysiol. 2025 May;48(5):471-479. doi:10.1111\/pace.15177. Epub 2025 Mar 28. PMID:40153431; PMCID:PMC12063197<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>ix <\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">Fink T, Sciacca V, Bannmann K, et al. First experience using a novel variable loop catheter for mapping and pulsed field ablation of atrial fibrillation. Pacing Clin Electrophysiol. 2025 Mar 28. doi:10.1111\/pace.15177. Epub ahead of print. PMID: 40153431.<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>x <\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">Laizzo PA. Handbook of Cardiac Anatomy, Physiology, and Devices. 2015. Springer Science+Business Media. LLC: Switzerland<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>xi <\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">Staerk L, Sherer JA, Ko D, Benjamin EJ, Helm RH. Atrial Fibrillation: Epidemiology, Pathophysiology, and Clinical Outcomes. Circ Res. 2017;120(9):1501-1517<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>xii <\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">Di Biase L, Zou F, Lin AN, et al.\u00a0Feasibility of Three-Dimensional Artificial Intelligence Algorithm Integration with Intracardiac Echocardiography for\u00a0Left Atrial Imaging During Atrial Fibrillation Catheter Ablation. Europace. 2023 Aug 2;25(9):euad211.<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>xiii <\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">Debreceni D, Janosi K, Bocz B, et al. (2023). Zero fluoroscopy catheter ablation for atrial fibrillation: a systematic review and meta-analysis. Front Cardiovasc Med;10:1178783. doi: 10.3389\/fcvm.2023.1178783<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>xiv <\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">Rajendra A, Hunter TD, Morales GX, et al. (2023). Steerable sheath visualizable under 3D electroanatomical mapping facilitates paroxysmal atrial\u00a0fibrillation ablation with minimal fluoroscopy. J Interv Card Electrophysiol;66(2):381-388. doi: 10.1007\/s10840-022-01332-8.<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>xv <\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">Tahin T, Riba A, Nemeth B, et al. (2021). Implementation of a zero fluoroscopic workflow using a simplified intracardiac echocardiography guided method for catheter ablation of atrial fibrillation, including repeat procedures. BMC Cardiovasc Disord;21(1):407. doi: 10.1186\/s12872-021-02219-8.<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>xvi <\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">Grimaldi M, Quadrini F, Caporusso N, et al. Deep sedation protocol during atrial fibrillation ablation using a novel variable-loop biphasic pulsed field ablation catheter. Europace. 2023;25(9):euad222. doi:10.1093\/europace\/euad222. PMID: 37470452; PMCID: PMC10434733.<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>xvii<\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">De Potter T,\u00a0Grimaldi M, Duytschaever M, Anic A, Vijgen J, Neuzil P, Van Herendael H, Verma A, Skanes A, Scherr D, P\u00fcrerfellner H, Rackauskas G, Jais P, Reddy VY, et al; inspIRE Trial Investigators. Predictors of success for pulmonary vein isolation with pulsed-field ablation using a variable-loop catheter with 3D mapping integration: complete 12-month outcomes from inspIRE. Circ Arrhythm Electrophysiol. 2024;17(5):e012667. doi:10.1161\/CIRCEP.123.012667. Epub 2024 Apr 24. PMID: 38655693; PMCID: PMC11111320.<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>xviii <\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">Reddy V, Grimaldi M, Duytschaever M, Anic A. Predictors of Success for Pulmonary Vein Isolation with Pulsed Field Ablation Using a Variable Loop Catheter with 3D Mapping Integration: Complete 12-month outcomes from inspIRE [abstract]. In: AF Symposium.; February 2-4; Boston.<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>xix <\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">Reddy V, Calkins H, Mansour M, et al.\u00a0<a href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=4463762-1&amp;h=4157243364&amp;u=https%3A%2F%2Fwww.ahajournals.org%2Fdoi%2Fabs%2F10.1161%2FCIRCULATIONAHA.124.070333&amp;a=Pulsed+field+ablation+to+treat+paroxysmal+atrial+fibrillation%3A+safety+and+effectiveness+in+the+admIRE+pivotal+trial\" target=\"_blank\" class=\"prnews_a\" rel=\"nofollow\">Pulsed field ablation to treat paroxysmal atrial fibrillation: safety and effectiveness in the admIRE pivotal trial<\/a>. Circulation. Published online September 11, 2024. doi: 10.1161\/CIRCULATIONAHA.124.070333.<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>xx <\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">Bessi\u00e8re F, Kronborg MB, Sommer P, et al. Evaluating Safety Profile and Learning Curve With a Pulsed Field Ablation Variable Loop Circular Catheter in Procedures for AF: Observations From a Prospective, Multicenter, Postmarket Clinical Trial. Presented at HRS 2025; April 27, 2025; San Diego, CA.<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>xxi <\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">Global Burden of Disease Collaborative Network (2017) Global Burden of Disease Study 2017 (GBD 2017) Results. Seattle, United States: Institute for Health Metrics and Evaluation (IHME), 2017. Accessed 2019-07-16. Available from http:\/\/ghdx.healthdata.org\/gbd-results-tool.<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>xxii <\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">American Heart Association . (2024, August 12).\u00a0<i>What are the symptoms of atrial fibrillation?<\/i>. www.heart.org. https:\/\/www.heart.org\/en\/health-topics\/atrial-fibrillation\/what-are-the-symptoms-of-atrial-fibrillation-afib-or-af<\/span> <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\"> <sup>xxiii <\/sup> <\/span> <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"> <span class=\"prnews_span\">Joglar JA, Chung MK, Armbruster AL, et al. 2023 ACC\/AHA\/ACCP\/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation: A Report of the American College of Cardiology\/American Heart Association Joint Committee on Clinical Practice Guidelines [published correction appears in Circulation. 2024 Jan 2;149(1):e167]. Circulation. 2024;149(1):e1-e156. doi:10.1161\/CIR.0000000000001193<\/span> <\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<p> <b>Media contacts:<\/b> <br \/>Carlos Taveras <br \/><a href=\"mailto:Ctaveras@its.jnj.com\" target=\"_blank\" rel=\"nofollow\">Ctaveras@its.jnj.com<\/a><br \/>Erin Farley<br \/><a href=\"mailto:Efarley1@its.jnj.com\" target=\"_blank\" rel=\"nofollow\">Efarley1@its.jnj.com<\/a>\u00a0<\/p>\n<p><!-- \/wp:html --><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"rop_custom_images_group":[],"rop_custom_messages_group":[],"rop_publish_now":"initial","rop_publish_now_accounts":[],"rop_publish_now_history":[],"rop_publish_now_status":"pending","footnotes":""},"categories":[5,7],"tags":[],"class_list":["post-26668","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cision-pr-newswire","category-cision-pr-newswire-en"],"_links":{"self":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts\/26668","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=26668"}],"version-history":[{"count":0,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts\/26668\/revisions"}],"wp:attachment":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=26668"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=26668"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=26668"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}