Johnson & Johnson has launched its Varipulse Pro pulsed field ablation (PFA) system in Europe following CE mark approval.

A new pulse sequence marks the next evolution of the Varipulse platform. J&J said it’s designed to boost procedural efficiency while reinforcing its established safety and effectiveness profile.

The newly debuted Varipulse Pro pulse sequence has a lower temperature profile and ablation that’s five times faster than the previous sequence while achieving equivalent lesions. It integrates with the Carto 3 system to offer advanced mapping capabilities, including tissue proximity indicators for precise delivery of lesions.

The first cases were performed under the VARIPURE postmarket follow-up study. J&J said it will generate rigorous evidence through the study and other clinical studies during the launch’s commercial phase.

“In our early experience, VARIPULSE Pro has been exceptionally smooth and easy to use,” said Tom De Potter, MD, Head of Electrophysiology and Associate Director of the Heart Center, OLV Hospital, Aalst, Belgium. “The speed is particularly striking and contributes to more efficient procedures without compromising precision. The integration with CARTO mapping and intracardiac echocardiography (ICE) facilitate accurate positioning and consistent lesion delivery, contributing to a very positive procedural experience.”

The company will introduce Varipulse Pro at the European Heart Rhythm Association (EHRA) annual meeting and present 12-month interim results from the ongoing VARIPURE study.

“The introduction of VARIPULSE Pro in Europe reflects our commitment to advancing our PFA platforms through continuous innovation, enhancing procedural experience while maintaining the consistency and precision physicians expect from the VARIPULSE Platform,” said Michael Bodner, Company Group Chair, Electrophysiology & Neurovascular, MedTech, Johnson & Johnson. “This launch demonstrates our dedication to continuously evolving PFA technologies based on real-world learnings and our scientific expertise, supporting physicians to deliver high-quality care and improved patient outcomes.”

Last month, the company received U.S. Food and Drug Administration (FDA) approval for Tecnis PureSee IOL, an extended depth of focus (EDOF) intraocular lens (IOL) used in cataract surgery.