Irvine, CA – March 31, 2025 – Johnson & Johnson MedTech, a global leader in cardiac arrhythmia treatment, announced 12-month results from the SmartfIRE study, presented as a late-breaking presentation at the annual meeting of the European Heart Rhythm Association (EHRA) in Vienna, Austria. The findings showed that the use of the Dual Energy THERMOCOOL SMARTTOUCH™SF Catheter was 86.9% effective when patients were treated with high adherence to the recommended ablation parameters. There was also a clinically meaningful improvement in quality of life and reduced healthcare utilization, with a significant reduction in total antiarrhythmic drug (AAD) use observed.1
The Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter is an irrigated, contact-force sensing catheter powered by the TRUPULSE™ Generator, and is fully integrated with the CARTO™ 3 System for advanced electro-anatomical mapping and for tag indexing.2 The platform is the first dual energy pulsed field ablation (PFA) / radiofrequency (RF) ablation catheter integrated with a PF and RF ablation index, which have proven to be important factors for durable lesion formation. The Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter is designed on the familiar platform of the RF THERMOCOOL SMARTTOUCH™ SF Catheter, with many years of physician experience. It received the European CE Mark approval in December 2024; it is currently investigational in the United States.
SmartfIRE was the first-in-human study assessing the safety and effectiveness of the Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter for the treatment of drug refractory symptomatic paroxysmal atrial fibrillation. Primary endpoints were met at the 3-month follow up[2]. The latest findings1 were observed among eligible participants completing 12-month follow-up[i], which include:
· 71.5% 12-month freedom from recurrence with protocol-required stringent monitoring; this rate increased to 86.9% among patients who were treated with high adherence to the recommended ablation workflow[ii]
· 3.6% serious adverse device effects (SADE) rate; the SADEs were not classified as related to PF energy[iii]
· 40.8% relative reduction in CV-related hospitalizations compared to baseline
· 60.4% relative reduction in Class I/III antiarrhythmic drug use (AAD) compared to baseline, with a significant reduction in total AAD use observed
“With the global incidence of AFib rising due to an aging population and the increasing prevalence of cardiovascular risk factors, there is a growing need for advanced, integrated technologies that support cardiac ablation procedures with clinical precision, proven efficacy, and optimized procedural efficiency,” said Tom De Potter, M.D., Head of Electrophysiology and Associate Director of the Heart Center, OLV Hospital, Aalst, Belgium.[iv] “With an efficacy rate of 86.9% with high adherence to the recommended ablation protocol leveraging the PF & RF Tag Index, the 12-month SmartfIRE data supports the effectiveness, safety, and clinical benefits of ablation performed with the Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter.”
Johnson & Johnson MedTech is also supporting the presentation of real-world evidence data from the company sponsored REAL AF Registry, a database comprised of 68 centers investigating real-world safety and effectiveness of catheter ablation procedures, health outcomes, research, and the future of electrophysiology practice. The data presented from the REAL AF Registry included those that examine gender differences in ablation strategies and outcomes, and outcomes with zero-fluoroscopy vs conventional approaches.
As part of its leadership in research to inform future clinical practice in catheter ablation, Johnson & Johnson MedTech is supporting additional studies with the Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter, as well as a number of investigator-initiated collaborative studies. The first patients have been enrolled in the GPfIRE collaborative study evaluating the impact of PF energy, both alone and in combination with RF energy, on vagal modulation after Pulmonary Vein Isolation (PVI) in PAF. Activation of the autonomic nervous system can induce changes to atrial electrophysiology. GPfIRE is designed to assess how ablation with PF and RF energy affects the autonomic nervous system and, in turn, heart rate variability.[3] The first cases were performed by Dr. Tom De Potter at OLV Hospital in Aalst, Belgium.
“At Johnson & Johnson MedTech, we recognize that advancing patient care requires strong collaborations and rigorous clinical research. By supporting studies like GPfIRE, we are committed to generating robust clinical evidence, especially for pulsed field ablation, that not only informs treatment decisions but also drives innovation in AFib care. Our goal is to empower clinicians with the insights needed to enhance workflows and optimize patient outcomes,” said Jennifer Currin, Ph.D., Vice President, Scientific Affairs, Johnson & Johnson MedTech.
In addition to the Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter, Johnson & Johnson MedTech is committed to offering a versatile portfolio of PFA products designed for seamless integration. Tools like the Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter and the VARIPULSE™ Platform work together to create optimal efficiency and compatibility in the treatment of cardiac arrhythmias.
About the Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter
The Dual Energy THERMOCOOL SMARTTOUCH™ SF Platform consists of the Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter[5] – an irrigated, contact-force sensing catheter – and the TRUPULSE™ Generator, providing both RF and PF energy to the catheter through the toggling of the two energy sources on the generator monitor2. The catheter and the generator are fully integrated with the CARTO™ 3 System, enabling advanced 3D mapping visualization with integrated ultrasound during ablation procedures.v The Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter is the first dual energy PFA / RF ablation catheter integrated with a PF and RF tag index.
About the SmartfIRE Study
SmartfIRE is an open-label interventional study evaluating the safety and efficacy of the investigational Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter with the TRUPULSE™ Generator, in the treatment of paroxysmal atrial fibrillation. The study enrolled 149 adult patients in Europe with drug refractory paroxysmal AFib, identified as candidates for catheter ablation, to receive PF or RF catheter ablation using the Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter and TRUPULSE™ generator during their cardiac ablation procedure. The study includes patients experiencing recurrent symptomatic atrial fibrillation following at least one AAD; class I to IV, or patients who can either not tolerate AAD or for whom AAD is contraindicated.[iv]
Cardiovascular Solutions from Johnson & Johnson MedTech
Across Johnson & Johnson, we are tackling the world’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, circular 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 biosensewebster.com and connect on LinkedIn and X, formerly Twitter.
About Johnson & Johnson
At Johnson & 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’s global scale and deep expertise in cardiovascular, orthopaedics, surgery and vision solutions at https://thenext.jnjmedtech.com. Biosense Webster, Inc. is part of Johnson & Johnson MedTech.
Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding the Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter. 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 Biosense Webster, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of regulatory approvals; uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; 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 healthcare products and services; and trends toward healthcare cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’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 sec.gov, jnj.com or on request from Johnson & Johnson. Neither Biosense Webster, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
© Johnson & Johnson and its affiliates 2025. All rights reserved. M_US_ELP_T
Footnotes
i Of 149 enrolled participants, 140 had the catheter enrolled and were included in the safety analysis set. The per-protocol analysis set used for effectiveness evaluation included the 136 participants who underwent ablation with the study catheter for the treatment of study-related arrhythmias without major protocol deviations.
ii 47 patients treated with high adherence, defined as >70% of applications with ablation index at ≥400 posteriorly and ≥500 anteriorly and ≥95% applications with ITD ≤6 mm
iii SADEs were reported at 12 months in the safety analysis set, n=140.
iv Cardiovascular Research Center Aalst entered into a clinical trial agreement with Johnson & Johnson Medical NV/SA for its participation in the SmartfIRE Clinical Trial and into a collaborative study agreement with Biosense Webster, Inc., part of Johnson & Johnson MedTech for GPfIRE. Dr. Tom De Potter served as a study investigator for SmartfIRE and was the principal investigator for GPfIRE. Dr. De Potter has received consultant fees from Johnson & Johson but was not compensated for his contributions to this announcement.
v Results reported after 9 months for patients with paroxysmal AFib who had failed 1 antiarrhythmic medication in randomized trial.
1 De Potter T, Scherr D, Pürerfellner H, et al. Safety, effectiveness, and healthcare benefits of a dual energy focal ablation technology to treat paroxysmal
atrial fibrillation: SmartfIRE 12-month results. Presented at EHRA 2025; March 31, 2025; Vienna, Austria. Pending formal publication.
2 Mattias Duytschaever, Gediminas Račkauskas, Tom De Potter, et al. Dual energy for pulmonary vein isolation using dual-energy focal ablation technology integrated with a three-dimensional mapping system: SmartfIRE 3-month results EP Europace, Volume 26, Issue 5, May 2024, euae088, https://doi.org/10.1093/europace/euae088
3 ClinicalTrials.gov. Evaluation of the Impact of Pulsed Field Ablation on Autonomic Nervous System Modulation in Paroxysmal Atrial Fibrillation (GPfIRE). https://clinicaltrials.gov/study/NCT06647485
4 ClinicalTrials.gov. Safety and Effectiveness Evaluation of the THERMOCOOL SMARTTOUCH™ SF Catheter with the TRUPULSE™ Generator for treatment of Paroxysmal Atrial Fibrillation (PAF) (SmartfIRE). https://clinicaltrials.gov/ct2/show/NCT05752487
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