CE Mark for Varipulse Platform for the treatment of symptomatic drug refractory recurrent paroxysmal atrial fibrillation

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.