Johnson & Johnson (J&J) has reported interim 12-month results from the VARIPURE study, assessing the effectiveness and safety of its Varipulse pulsed field ablation (PFA) platform in first-time users.
The findings were unveiled at the 2026 European Heart Rhythm Association (EHRA) Annual Meeting in Paris, France, and published in Europace.
At 12 months, the study reported 84.2% of patients experienced freedom from all documented atrial arrhythmia recurrence, with 90.5% for those with paroxysmal atrial fibrillation (AFib) and 75.3% for persistent cases.
These rates are based on Kaplan–Meier estimates. The safety profile showed a primary adverse event (PAE) rate of 0.8% and no incidences of strokes, coronary spasm, or other PFA-related complications.
The complete study cohort includes 1,023 patients from 22 sites in Europe, with 442 completing the 12-month follow-up at the time of analysis.
Additionally, 29.7% of participants received ablation procedures beyond the pulmonary veins, highlighting the flexibility of the Varipulse platform.
J&J electrophysiology chief medical and scientific officer Gregory Michaud said: "Varipure represents a significant step forward in the evolution of pulsed field ablation, demonstrating strong results in a real-world clinical setting as Varipulse use expands.
“The observations in persistent AFib 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 AFib and complex arrhythmias.”
J&J has also confirmed that the Varipulse catheter has received an updated CE mark, permitting ablation outside the pulmonary veins in Europe following approval by German certification company DEKRA. This regulatory change enables expanded workflows for treating persistent AFib and reflects growing clinical support for the platform.
The Varipulse platform consists of the Varipulse catheter, Trupulse generator, Carto 3 mapping system, and Varipulse software.
Earlier this month, J&J launched Varipulse Pro in Europe after securing CE Mark approval, strengthening its PFA portfolio.
