Johnson & Johnson (J&J) has announced favourable 12-month interim effectiveness and safety results from VARIPURE—the largest prospective post-market follow-up study evaluating first-time pulsed field ablation (PFA) using the company’s Varipulse platform. These data were presented at the PFA Summit during the annual congress of the European Heart Rhythm Association (EHRA; 12–14 April 2026, Paris, France) and simultaneously published in EP Europace.
“The VARIPURE results adds important real-world evidence demonstrating that PFA with the Varipulse platform can deliver both durable effectiveness and a consistently strong safety profile across a broad AF [atrial fibrillation] population,” said Daniel Scherr (Medical University of Graz, Graz, Austria). “What is particularly compelling is the combination of sustained 12-month outcomes and strong safety profile, which are critical indicators of long-term treatment success in everyday clinical practice.”
As per a press release from J&J, key 12-month highlights from these data include:
- High effectiveness with 84.2% freedom from all documented atrial arrhythmia recurrence at 12 months, including 90.5% for paroxysmal patients and 75.3% for persistent patients, based on Kaplan-Meier estimates
- A strong safety profile with a 0.8% primary adverse event (PAE) rate and zero reported strokes, coronary spasm or other PFA-related complications
- A complete cohort including 1,023 patients across 22 European centres, with 442 patients completing 12-month follow-up at the time of analysis
- Some 29.7% of patients were treated beyond the pulmonary veins, demonstrating the versatility of the Varipulse platform
“VARIPURE represents a significant step forward in the evolution of PFA, demonstrating strong results in a real-world clinical setting as Varipulse use expands,” commented Gregory Michaud, chief medical and scientific officer of electrophysiology at J&J. “The observations in persistent AF patients, along with meaningful experience outside pulmonary vein isolation, speak to the platform’s versatility across a wide range of patient types and ablation strategies. A continuous commitment to rigorous evidence generation and deep scientific expertise will further elevate the standard of care for patients with AF and complex arrhythmias.”
Additionally, J&J has announced CE-mark approval to update the instructions for use (IFU) of the Varipulse catheter to allow ablation outside the pulmonary veins in Europe following approval from German certification company DEKRA based on real-world data. According to J&J, this change also enables workflows for the treatment of patients with persistent AF, and reflects the growing clinical evidence supporting the technology.
