Biosense Webster inspIRE clinical study demonstrates 80% freedom from atrial arrhythmia recurrence at 12 months

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Final results from inspIRE study demonstrate 80% freedom from atrial arrhythmia recurrence at 12 months in patients with optimal Pulsed Field Ablation applications*.

Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson MedTech , announced 12-month results from the company-sponsored inspIRE study, “Predictors of Success for Pulmonary Vein Isolation with Pulsed Field Ablation (PFA) Using a Variable Loop Catheter with 3D Mapping Integration: Complete 12-month outcomes from inspIRE,” presented as a late-breaking presentation at the 29th Annual International AF Symposium.1

The inspIRE clinical study was conducted using the Biosense Webster VARIPULSE™ Platform, consisting of the VARIPULSE™ Catheter – a fully integrated variable-loop multielectrode catheter; the TRUPULSE™ Generator – a multichannel PFA generator; and the CARTO™ 3 System VARIPULSE™ Service Pack Software, which provides full integration with the world’s leading 3D cardiac mapping system. The CARTO™ System enables an intuitive and reproducible workflow with real-time visualization and feedback mechanisms.

Data from inspIRE Demonstrate 80% of Patients Achieved Freedom from Recurrence with Zero Primary Adverse Events

The inspIRE study evaluated the safety and effectiveness of the VARIPULSE™ Platform for the treatment of drug-refractory paroxysmal AFib in Europe and Canada.i In the study, the primary effectiveness endpoint of acute pulmonary vein isolation and 12-month freedom from atrial arrhythmia recurrence (AFib, Atrial Tachycardia, or Atrial Flutter) was 75.6%. Among participants receiving optimal PFA applications, 80% achieved the primary effectiveness endpoint.i The study reported a low fluoroscopy time of 7.8 minutes, partly attributed to the integration of the VARIPULSE™ Platform to the CARTO™ 3 System. The safety results demonstrated a primary adverse event rate of 0.0%.2,i

“High efficacy of 80% freedom from atrial recurrence at 12 months and a strong safety profile are promising evidence of the capabilities of the VARIPULSE™ Platform,” said Vivek Y. Reddy, M.D., Director of Electrophysiology at the Mount Sinai Fuster Heart Hospital and The Helmsley Trust Professor of Cardiac Electrophysiology at the Icahn School of Medicine at Mount Sinai, corresponding author for the inspIRE study publication.3 “As the VARIPULSE™ Platform was designed to integrate seamlessly with the CARTO™ 3 Mapping System, this technology should be able to effectively treat patients with atrial fibrillation with low radiation exposure to patients and lab staff alike.”

“Biosense Webster is committed to bringing forward a versatile, differentiated portfolio of PFA solutions designed to help electrophysiologists deliver safe, effective, and efficient cardiac ablation procedures,” said Jasmina Brooks, President, Biosense Webster, Inc. “The encouraging outcomes from the clinical trial with VARIPULSE™ fuel our excitement as we continue to deliver innovations to meet the diverse needs and ablation strategies required to successfully treat atrial fibrillation.”

About inspIRE
The inspIRE study (Study for Treatment of Paroxysmal Atrial Fibrillation [PAF] by PFA System With Irreversible Electroporation [IRE]) (NCT04524364) was a prospective, multi-center, single-arm study of drug-refractory PAF, conducted at 13 institutions in Canada and Europe, from March 2021 to May 2022. In the study, PVI was performed with the VARIPULSE™ Platform. Follow up with 24-hour Holter monitoring was performed at three, six, and 12 months. Remote rhythm monitoring was performed weekly from three to five months; monthly, from six to 12 months; and for symptoms. The primary effectiveness endpoint (PEE) was acute PVI plus freedom from all atrial arrhythmia (AFib, Atrial Tachycardia, or Atrial Flutter), at 12 months. This final analysis of the study focused on the pivotal phase (Wave II) per-protocol population of 186 patients with 12 months of follow up.

About the VARIPULSE™ Platform
The VARIPULSE™ Platform is Biosense Webster’s Irreversible Electroporation ablation system. The fully integrated platform includes the VARIPULSE™ Catheter, TRUPULSE™ Generator, and CARTO™ 3 Mapping System VARIPULSE™ Service Pack Software. In January 2024, Biosense Webster announced that the VARIPULSE™ Platform received its first regulatory approval from the Japan Ministry of Health, Labour and Welfare for the treatment of symptomatic drug refractory recurrent paroxysmal AFib using PFA. In the U.S., the VARIPULSE™ Catheter and TRUPULSE™ Generator are currently investigational and are not approved by regulatory authorities. In Europe, the TRUPULSE™ generator was awarded the CE mark in late 2023, while the VARIPULSE™ Catheter received its CE mark in February 2024.

* Based on the final analysis of the InspIRE study focused on the pivotal phase (Wave II) per-protocol population of 186 patients with 12 months of follow up.

i. 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.

  1. Johnson & Johnson MedTech comprises the surgery, orthopedics, vision, and interventional solutions businesses within Johnson & Johnson’s MedTech segment.
  2. Primary adverse events were defined as myocardial infarction, thromboembolism, transient ischemic attack, diaphragmatic paralysis, pneumothorax, heart block, pulmonary edema, vagal nerve injury, pericarditis, major vascular access complication or bleeding, death, stroke, or any other cerebrovascular accident. Atrioesophageal fistula and PV stenosis occurring >7 days post ablation along with cardiac tamponade or perforations occurring within 30 days of the ablation procedure were also considered primary adverse events.
  3. 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.

© Johnson & Johnson Medical NV/SA 2024