Johnson & Johnson has introduced its latest Varipulse Pro system in Europe, marking the regional debut of its next-generation pulsed field ablation technology following CE mark clearance. The updated system represents an advancement of the company’s pulsed field ablation platform designed for the treatment of atrial fibrillation (AFib), with a focus on improving both workflow efficiency and clinical performance.
At the core of the launch is a redesigned pulse sequence, which delivers ablation significantly faster than earlier iterations while maintaining equivalent lesion outcomes. According to the company, the updated system operates with a lower temperature profile and achieves ablation speeds up to five times faster than the previous sequence. Built on the foundation of the Varipulse platform that received CE mark approval in 2024, the system enters an increasingly competitive European market that includes technologies such as Volt (Abbott), Farapulse (Boston Scientific), PulseSelect (Medtronic), Globe (Kardium), Centauri (CardioFocus) and PulseMagic (MicroPort EP). The Varipulse PFA catheter is positioned as a continuation of Johnson & Johnson’s iterative approach to innovation in electrophysiology.
“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.”
The system maintains compatibility with the Carto 3 mapping system, which provides 3D cardiac mapping capabilities used in electrophysiology procedures. This integration enables features such as tissue proximity indicators to support accurate lesion placement. Early clinical use has been carried out within the VARIPURE multicenter, prospective, post-market follow-up study, with further data generation planned as part of the broader commercial rollout. The company also intends to present the technology and related findings at the European Heart Rhythm Association annual meeting and the EHRA PFA summit. The Varipulse PFA catheter remains investigational in the U.S.
“In our early experience, Varipulse Pro has been exceptionally smooth and easy to use,” said Dr. Tom De Potter, 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.”
