First Look at Data on Biosense Webster's Investigational Pulsed Field Ablation Platform Presented at AF Symposium 2023

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Feb 03, 2023, 19:04 ET

Late breaking analysis of one-year outcomes from the inspIRE clinical study demonstrated early success at the prespecified interim analysis

IRVINE, Calif., Feb. 3, 2023 /PRNewswire/ -- Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson MedTech,ⁱ announced that positive results from the inspIRE company-sponsored clinical trial were presented as a late breaker, titled "Paroxysmal AF Ablation Using a Variable-Loop Pulsed Field Ablation Catheter Integrated with a 3D Mapping System: One-Year Outcomes from inspIRE," at the 28th Annual International AF Symposium.

In addition to being presented as an AF Symposium late breaker, the data will be simultaneously published in Circulation: Arrhythmia and Electrophysiology. To review the article online, click here.

"The inspIRE study achieved early success at the prespecified interim analysis, meeting both primary safety and efficacy endpoints, achieving an important milestone in the development of the novel, mapping-integrated, variable-loop, pulsed field ablation catheter," said Vivek Y. Reddy, MD, Director of Cardiac Arrhythmia Services at The Mount Sinai Hospital and the Mount Sinai Health System, and The Leona M. and Harry B. Helmsley Charitable Trust Professor of Medicine in Cardiac Electrophysiology at Icahn School of Medicine at Mount Sinai.ⁱⁱ "PFA is a new frontier in cardiac ablation and seeing these interim results reinforces electrophysiologists' enthusiasm for this innovative technology."

Pulsed Field Ablation (PFA) represents a new approach to treating atrial fibrillation (AFib), utilizing a controlled electric field to ablate cardiac tissue through a process called irreversible electroporation (IRE). Because the energy does not rely on thermal effects to ablate target cardiac tissue, IRE offers the potential to reduce the risk of esophageal, pulmonary vein and phrenic nerve injury.

The inspIRE clinical trial conducted in Europe is a prospective, multicenter, nonrandomized study evaluating the safety and efficacy of the VARIPULSE™ Catheter and TRUPULSE™ Generator in treating symptomatic drug refractory recurrent paroxysmal AFib.¹ It is the first clinical study for the PFA system with full electroanatomical mapping system integration.

Across 13 centers, 226 patients were enrolled (wave I-40, wave II-186). There were no esophageal thermal lesions, pulmonary vein stenosis, or coronary spasm assessed in wave I cohort. In wave II, an independent Data Monitoring Committee declared early success after 186-patient enrollment and 60 patients completing 12-month follow-up. No primary adverse events were reported (0%). With 100% entrance block, pulmonary vein isolation (PVI) without acute reconnection was achieved in 97.1% of targeted veins. Primary efficacy was achieved in 70.9%, 12-month freedom from symptomatic AFib/atrial flutter/atrial tachycardia recurrence and repeat ablation was 78.9% and 92.3%, respectively.²

The VARIPULSE™ Catheter is Biosense Webster's investigational technology and is not yet approved by regulatory bodies in any market today. VARIPULSE™ is a steerable, multielectrode, catheter enabling cardiac electrophysiological mapping and ablation functionalities through the investigational TRUPULSE™ Generator. The investigational catheter uses PFA in treating symptomatic drug refractory recurrent paroxysmal (intermittent) AFib. It is designed to be used with the CARTO™ 3 System, enabling mapping integration to the application of PF energy.

"PFA is the next frontier in AFib treatment and may have a variety of benefits, including a better safety profile than RF ablation, without sacrificing long term effectiveness," said Anthony Hong, Vice President, Preclinical and Clinical Research and Medical Affairs, Biosense Webster, Inc. "Biosense Webster is working to bring a versatile portfolio of PFA solutions – complementary to our RF ablation catheter portfolio – to address various ablation strategies in the treatment of AFib."

In addition to the inspIRE clinical trial in Europe, Biosense Webster is conducting the admIRE clinical study in the United States to evaluate the safety and effectiveness of its investigational PFA system.

About inspIRE
The inspIRE clinical trial conducted in Europe is a prospective, multicenter, nonrandomized study evaluating the safety and efficacy of the VARIPULSE™ Catheter and TRUPULSE™ Generator in treating symptomatic drug refractory recurrent paroxysmal AFib.¹ It is the first clinical study for the PFA system with full electroanatomical mapping system integration.

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 www.biosensewebster.com and connect on LinkedIn and Twitter.

About Johnson & Johnson MedTechⁱAt Johnson & Johnson MedTech,ⁱwe 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, orthopaedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalized.

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 investigational VARIPULSE ™ Pulse Field Ablation catheter and TRUPULSE™ Generator. 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 Biosense Webster, Inc., any of the other Johnson & Johnson MedTech Companies 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 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 & Johnson's Annual Report on Form 10-K for the fiscal year ended January 2, 2022, 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 www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither Biosense Webster, Inc., the Johnson & Johnson MedTech Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

ⁱ Johnson & Johnson MedTech comprises the surgery, orthopedics, vision and interventional solutions businesses within Johnson & Johnson's MedTech segment.
ⁱⁱ Nemocnice na Homolce entered into a clinical trial agreement with Johnson & Johnson Medical NV/SA for their participation in the inspIRE Study. Dr. Reddy served as a study coinvestigator. Dr. Reddy was compensated for consultancy purposes for his Multielectrode IRE Catheter Program Study Advisory Committee membership. Dr. Reddy was not compensated for this authorship contributions.

¹ ClinicalTrials.gov. A Study for Treatment of Paroxysmal Atrial Fibrillation (PAF) by Pulsed Field Ablation (PFA) System With Irreversible Electroporation (IRE) (inspire). https://clinicaltrials.gov/ct2/show/NCT04524364#contacts. Accessed January 11, 2023.
² Reddy,Vivek., et al. Paroxysmal AF Ablation Using a Variable-Loop Pulsed Field Ablation Catheter Integrated with a 3D Mapping System: One-Year Outcomes from inspIRE [abstract]. In: AF Symposium.; February 2–4; Boston

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SOURCE Biosense Webster, Inc.