Biosense Webster, a unit of Johnson & Johnson MedTech, said that its Varipulse platform has demonstrated positive results in the inspIRE and admIRE clinical trials.
The Varipulse platform consists of the Varipulse Catheter, Trupulse Generator, and the CARTO 3 System Varipulse Service Pack Software.
According to Johnson & Johnson MedTech, the Varipulse Catheter is a variable-loop multielectrode catheter, while the Trupulse Generator is a multichannel pulsed field ablation (PFA) generator. The Varipulse software is designed to provide full integration with the 3D cardiac mapping system.
The inspIRE study assessed the safety and effectiveness of the platform to treat drug-refractory paroxysmal atrial fibrillation (AFib) in Europe and Canada.
It found that the primary effectiveness endpoint, which measured acute pulmonary vein isolation and 12-month freedom from atrial arrhythmia recurrence, was achieved in 75.6% of cases. Specifically, among participants who received optimal PFA applications, 80% reached this primary effectiveness endpoint.
In the pilot phase of the admIRE study, 100% of enrolled patients experienced acute success from ablation procedures, and 80% remained free from atrial arrhythmia recurrence after one year.
Biosense Webster president Jasmina Brooks said: “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.
“The encouraging outcomes from clinical trials 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.”
The inspIRE study was a prospective, multi-centre, single-arm trial in drug-refractory paroxysmal atrial fibrillation (PAF).
The primary effectiveness endpoint (PEE) was defined as the acute pulmonary vein isolation (PVI) plus freedom from all atrial arrhythmia at 12 months.
The admIRE study assessed the safety and long-term effectiveness of the Varipulse platform for use in the isolation of pulmonary veins in patients with symptomatic drug refractory paroxysmal AFib.
The study included a pilot phase, which evaluated initial device safety and effectiveness, and a pivotal phase, which assessed these against pre-specified performance targets.
The primary safety endpoint was the incidence of early onset primary adverse events, atrio-esophageal fistula, cardiac tamponade or perforation, and PV stenosis.
Last month, Japan’s Ministry of Health, Labour and Welfare (MHLW) approved the Varipulse platform.
