At a Glance
Varipulse Pro offers a lower temperature profile and an ablation that is five times faster than the previous sequence.
Integrated with Carto 3 system, Varipulse Pro enhances mapping and lesion delivery for efficient procedures.
J&J plans to feature the Varipulse Pro at EHRA, including live case demos, hands-on training, and professional education.
Johnson & Johnson has launched the Varipulse Pro in Europe following CE mark approval, further advancing its pulsed-field ablation (PFA) portfolio. This new pulse sequence marks the next evolution of the company’s Varipulse Platform and is designed to improve procedural efficiency while reinforcing its established safety and effectiveness profile, J&J noted.
Varipulse Pro introduces a new pulse sequence with a lower temperature profile and an ablation that is five times faster than the previous sequence while achieving equivalent lesions.
According to the company, Varipulse Pro builds on the precision and safety profile of the Varipulse platform and integrates with the Carto 3 system, using advanced mapping capabilities, including tissue proximity indicators for precise lesion delivery. With initial cases performed under the VARIPURE multicenter, prospective, post-market follow-up study, the company aims to generate rigorous evidence through VARIPURE and additional clinical studies during the commercial phase of the launch.
“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.”
J&J said it will feature the Varipulse Pro at the European Heart Rhythm Association (EHRA) annual meeting, including live case demonstrations, hands-on training sessions, and professional education. In addition, 12-month interim results from the ongoing VARIPURE study evaluating pulsed field ablation with the Varipulse platform will be presented at the EHRA PFA Summit by Daniel Scherr, a professor of electrophysiology at the Medical University of Graz.
“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.”
PFA competitive landscape
Pulsed field ablation has emerged as one of the hottest sectors since drug-eluting stents. J&J competes with Medtronic, Boston Scientific, Abbott, and others in PFA.
“There are many new technologies coming in PFA and with more commercial options, we expect this to be another fast year of evolution for PFA,” Marie Thibault, a BTIG medtech analyst, wrote in a Feb. 9 note.
In the same report, the analyst noted a spate of recent approvals in PFA for several companies, including: Boston Scientific securing FDA approval for Farapoint, Abbott gaining FDA approval for Volt and CE mark for Tactiflex Duo Sensor-Enabled catheter, Medtronic getting a CE mark for Sphere-360, and J&J introducing the Varipulse Plus with automated irrigation flow. Thibault also pointed to PFA technologies and activities still in the pipeline, such as Boston Scientific’s Faraflex, Medtronic’s U.S. pivotal trial for Sphere-360, J&J’s Omnypulse, Pulse Biosciences’ nPulse nsPFA catheter, and more.
