The VARIPULSE Platform is comprised of the VARIPULSE Catheter, a variable-loop multielectrode catheter; the TRUPULSE Generator, a multichannel PFA generator; and CARTO 3 System, a 3D cardiac mapping system. The VARIPULSE Platform is the only CARTO integrated PFA system, enabling an intuitive and reproducible workflow with real-time visualisation 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.

Tom De Potter, associate director, Cardiovascular Center, OLV Hospital Aalst, Belgium, said: “CE mark approval of the VARIPULSE Platform represents a significant advance in catheter ablation technology, allowing electrophysiologists to offer patients in Europe pulsed field ablation treatment with real-time integrated 3D mapping. Significantly, the VARIPULSE Platform is fully integrated with the CARTO 3 System, enabling a simplified workflow with minimal fluoroscopy time. Most importantly, the recent published data on the VARIPULSE Platform demonstrates the safety using pulsed field ablation for patients being treated for AF.”