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Biosense Webster receives CE mark for VARIPULSE PFA Platform

Biosense Webster, a cardiac arrhythmia treatment specialist and part of Johnson & Johnson MedTech, has received CE mark approval for the VARIPULSE Platform for the treatment of symptomatic drug refractory recurrent paroxysmal atrial fibrillation (AF) using pulsed field ablation (PFA).
Biosense Webster receives CE mark for VARIPULSE PFA Platform

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.”

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