Biosense Webster, a part of Johnson & Johnson MedTech, has received the CE mark approval for its Varipulse pulsed field ablation (PFA) Platform to treat a type of atrial fibrillation (AF)

The Varipulse Platform, which comprises the Varipulse Catheter, Trupulse Generator, and Carto 3 System, is intended to treat symptomatic drug refractory recurrent paroxysmal AF.

Varipulse Catheter is a variable-loop multielectrode catheter, Trupulse Generator is a multichannel PFA generator and Carto 3 System is a 3D cardiac mapping system.

According to the company, the Varipulse Platform is the first and only Carto-integrated PFA system that enables reproducible workflow with real-time visualisation and feedback set-up.

Biosense Webster president Jasmina Brooks said: “At Biosense Webster, we continually seek to push the boundaries of science and technology innovation in cardiac ablation.

“CE mark approval of the VARIPULSE Platform is testament to this, now offering healthcare professionals the potential to improve outcomes for people living with atrial fibrillation while setting a new standard in cardiac electrophysiological mapping.

“We believe pulsed field ablation has the potential to offer safer, more consistent and efficient workflows, and the VARIPULSE Platform uniquely offers physicians a simple and reproducible PFA workflow with 3D visualization, in real-time.”

Biosense Webster said that the safety and efficacy of the Varipulse Platform were validated in the inspIRE trial, which included 186 patients in Canada and Europe.

In the study, 80% of the participants who received optimal PFA applications, reached the primary effectiveness endpoint, freedom from recurrence with no primary adverse events.

Also, the primary effectiveness endpoint (PEE) of acute pulmonary vein isolation and 12-month freedom from atrial arrhythmia recurrence (AF, Atrial Tachycardia, or Atrial Flutter).

The combination of the Varipulse Catheter and Carto 3 System in the study partly resulted in a low fluoroscopy time of 7.8 minutes, and a good safety profile with no primary adverse events.

Earlier this year, Biosense Webster secured Japan’s Ministry of Health, Labour and Welfare (MHLW) approval for the Varipulse pulsed field ablation (PFA) platform.