CE Mark for Varipulse Platform for the treatment of symptomatic drug refractory recurrent paroxysmal atrial fibrillation – Biosense Webster (J&J)

Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson MedTech, announced European CE mark approval of the Varipulse Platform for the treatment of symptomatic drug refractory recurrent paroxysmal atrial fibrillation (AF) using pulsed field ablation (PFA).

The Varipulse Platform is comprised of the Vaipulse Catheter, a variable-loop multielectrode catheter; the Trupulse Generator, a multichannel PFA generator; and Carto 3 System, the world’s leading 3D cardiac mapping system. The Varipulse Platform is the first and only Carto -integrated PFA system, enabling an intuitive and reproducible workflow with real-time visualization and feedback mechanisms.

The safety and efficacy of the Varipulse Platform was investigated in the inspIRE trial, which included 186 patients in Canada and Europe Updated one-year follow-up data was presented this month at the AF Symposium in Boston, demonstrating that among participants receiving optimal PFA applications, 80% achieved freedom from recurrence with zero primary adverse events. Furthermore, the primary effectiveness endpoint (PEE) of acute pulmonary vein isolation and 12-month freedom from atrial arrhythmia recurrence (AF, Atrial Tachycardia, or Atrial Flutter) was 75.6%. The study reported a low fluoroscopy time of 7.8 minutes, partly attributed to the integration of the Varipulse Catheter to the Carto 3 System and a good safety profile with no (0.0%) primary adverse events reported.