First Look at Data on Biosense Webster Dual Energy THERMOCOOL SMARTTOUCH™ SF Platform for Atrial Fibrillation Presented at EHRA Congress

Irvine, CA (April 9, 2024) – Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson MedTech, today announced three-month follow-up results from the SmartfIRE clinical trial, unveiled in a late-breaking presentation by Dr. Tom De Potter,ⁱ an investigator in the study, during the annual meeting of the European Heart Rhythm Association (EHRA) in Berlin, Germany.¹ The findings showed that the use of the Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter during standard electrophysiology mapping and ablation procedures in drug refractory symptomatic paroxysmal AFib patients led to a 100% acute procedural success, with 96.8% no acute reconnections shown in the veins.¹ The Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter is the first dual energy pulsed field ablation (PFA) / radiofrequency (RF) ablation catheter integrated with a PF and RF ablation index.

The ablation system evaluated in the SmartfIRE study consists of the Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheterii – 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 monitor.² The catheter and the generator are fully integrated with the world’s leading CARTO™ 3 System, enabling live 3D mapping and advanced visualization during ablation procedures.ⁱⁱ

"Early results from the SmartfIRE study show that the use of the Dual Energy THERMOCOOL SMARTTOUCH™ SF ablation system led to complete 3-month acute procedural success in patients with paroxysmal AFib, while demonstrating the seamless transition of ablation workflow to a dual energy platform,” said Mattias Duytschaever, M.D., Ph.D., Department of Cardiology, Electrophysiology Section, AZ Sint-Jan Hospital, Brugge, Belgium,ⁱⁱⁱ an investigator in the study. “Having the ability to easily switch between RF and PF energy provides the flexibility to customize treatment depending on the patient anatomy and clinical need, enabling electrophysiologists to perform more targeted ablation procedures which could lead to improved outcomes for patients.”

SmartfIRE is a prospective, multi-center, single-arm study evaluating the safety and efficacy of the Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter with the TRUPULSE™ Generator, in the treatment of patients with recurrent paroxysmal AFib in Europe (NCT05752487).³ When used for isolation of the atrial pulmonary veins (PVs) in the treatment of patients with paroxysmal AFib (N=137), catheter ablation using PF and RF enabled a total energy application time of median 12.8 min and fluoroscopy exposure of 4.2 minutes.1 Primary adverse events in the SmartfIRE study were seen in 4.4 percent of patients (N=137). Prespecified remapping performed at 75 (+/-15) days post-procedure in subset of patients showed 87% of targeted veins as durable isolated.

“The initial results from the SmartfIRE trial suggest that the Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter, together with the TRUPULSE™ Generator and the CARTO™ 3 System, is a promising advancement in cardiac ablation,” said Jennifer Currin, Ph.D., Vice President, Scientific Affairs, Cardiovascular & Specialty Solutions Group at Johnson & Johnson MedTech. “As Biosense Webster works to develop a versatile portfolio of PFA solutions, we believe that the Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter will be a valuable addition to the set of tools electrophysiologists use to address diverse ablation strategies in the treatment of atrial arrhythmias.”

AFib is the most common type of cardiac arrhythmia, currently affecting more than 50 million people globally,³ and over 11 million people in Europe.^4,5,6 If left untreated, patients face a 2.4-fold increased risk of stroke,⁷ while their risk of death doubles.⁸ By 2030, the number of people with AFib is projected to increase by up to 70 percent,⁹ and given its increasing prevalence around the world, physicians are looking for innovative ways to deliver better treatment outcomes.

Catheter ablation is a minimally invasive procedure performed by an electrophysiologist to treat heart rhythm disorders, including AFib, by interrupting irregular electrical pathways in the heart, through the delivery of either heat (RF ablation) or cold (Cryoablation).¹⁰ PFA represents a new approach to treating AFib, utilizing a controlled electric field to selectively ablate cardiac tissue that causes the irregular heartbeat through a process called irreversible electroporation (IRE).¹¹ Because the energy does not rely on thermal effects to ablate target cardiac tissue, IRE offers the potential to reduce the risk of damage to surrounding tissues.¹²

Learn more about Biosense Webster's PFA research and clinical evidence here.

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, who received pulsed field (PF) or radiofrequency (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 antiarrhythmic drug (AAD; class I to IV), or patients who can either not tolerate AAD or for whom AAD is contraindicated. SmartfIRE started in February 2023, with patients in Austria, Belgium, Denmark, and Lithuania, and is due to complete at the end of 2024.

ABOUT BIOSENSE WEBSTER

Biosense Webster, Inc. is the global market leader in the science and technology behind the diagnosis and treatment of cardiac arrhythmias. Part of Johnson & Johnson MedTech, the specialized medical technology company is headquartered in Irvine, California, and works across the world to advance the tools and solutions that help electrophysiologists identify, treat, and deliver care. Learn more at http://www.biosensewebster.com/ and connect on LinkedIn and X, formerly Twitter.

ABOUT JOHNSON & JOHNSON MEDTECH

At Johnson & Johnson MedTech, we unleash diverse healthcare expertise, purposeful technology, and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible. For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health. In surgery, orthopedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalized.

i Cardiovascular Research Center Aalst entered into a clinical trial agreement with Johnson & Johnson Medical NV/SA for its participation in the SmartfIRE Clinical Trial. Dr. Tom DePotter serves as a study investigator and was not compensated for his contributions to this announcement. 

ii The Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter is currently investigational and is not available for sale in any region. 

iii AZ Sint-Jan Brugge Oostende AV entered into a clinical trial agreement with Johnson & Johnson Medical NV/SA for its participation in the SmartfIRE Clinical Trial. Dr. Mattias Duytschaever serves as a study investigator and was not compensated for his contributions to this announcement

1 Duytschaever M, et al. Safety, effectiveness and PVI durability of contact force-sensing dual energy focal ablation technology integrated with 3D mapping to treat paroxysmal atrial fibrillation: SmartfIRE study results. Presented during the annual meeting of the European Heart Rhythm Association (EHRA), on 9th April 2024, Berlin, Germany. 

2 ClinicalTrials.gov. A Study For Treatment Of Paroxysmal Atrial Fibrillation (PAF) With The THERMOCOOL SMARTTOUCH SF Catheter and TRUPULSE Generator (SmartfIRE). Available at: https://classic.clinicaltrials.gov. Last accessed: April 2024. 

3 Mensah, G, Fuster, V, Murray, C. et al. Global Burden of Cardiovascular Diseases and Risks, 1990-2022. J Am Coll Cardiol. 2023 Dec, 82 (25) 2350–2473. Available at: https://doi.org. Last accessed: April 2024.. 

4 Waktare JEP. Atrial Fibrillation. Circulation 2002;106:14-16. 

5 Velleca M, et al. A Review of the Burden of Atrial Fibrillation: Understanding the Impact of the New Millennium Epidemic across Europe. EMJ Cardiol 2019; 7[1]:110-118. 

6 Ball J, et al. Atrial fibrillation: profile and burden of an evolving epidemic in the 21st century. Int J Cardio 2013;167(5):1807-1824. 

7 Odutayo A, Wong CX, Hsiao AJ, Hopewell S, Altman DG, Emdin CA. Atrial fibrillation and risks of cardiovascular disease, renal disease, and death: systematic review and meta-analysis. BMJ. 2016;354:i4482. Published 2016 Sep 6. doi:10.1136/bmj.i4482. 

8 Odutayo A, et al. Atrial fibrillation and risks of cardiovascular disease, renal disease and death: systematic review and meta-analysis. BMJ 2016;354:4482. 

9 Zoni-Berisso M, et al. Epidemiology of atrial fibrillation: European perspective. Clin Epidemiol 2014;6:213-220. 

10 British Heart Foundation. Catheter Ablation. Available at: https://www.bhf.org.uk. Last accessed: January 2024. 

11 Reddy VY, et al. Pulsed Field Ablation for Pulmonary Vein Isolation in Atrial Fibrillation. JACC 2019;74(3)315-326.