February 14, 2023 — 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.
For more information: www.biosensewebster.com
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