Johnson & Johnson reports positive 12‑month VARIPULSE results at EHRA 2026
- VARIPURE post‑market study (1,023 patients across 22 centers; 442 completed 12‑month follow‑up) reported 84.2% freedom from documented atrial arrhythmia at 12 months (90.5% paroxysmal; 75.3% persistent).
- Safety: 0.8% primary adverse event rate with zero reported strokes or coronary spasm; patients without ≥90 days follow‑up were excluded from the safety evaluation unless they had a PAE.
- CE‑mark updated VARIPULSE IFU to allow ablation outside the pulmonary veins in Europe; VARIPULSE remains indicated in the U.S. for paroxysmal AF and 29.7% of study patients were treated beyond the pulmonary veins.
Study results
VARIPURE 12‑month interim data from the largest prospective post‑market follow‑up of first‑time pulsed field ablation with the VARIPULSE Platform reported 84.2% freedom from documented atrial arrhythmia at 12 months (Kaplan–Meier), with 90.5% for paroxysmal and 75.3% for persistent patients; 442 patients completed 12‑month follow‑up at time of analysis.
Safety
Primary adverse event rate was 0.8% with no reported strokes, coronary spasm or other PFA‑related complications; patients with <90 days follow‑up were excluded from safety evaluation unless they experienced a PAE.
Study design and cohort
VARIPURE is a prospective, observational, multicenter postmarket substudy of SECURE across 22 European centers including 1,023 patients, using preprocedure consent, electronic data capture, monitoring and data cleaning to enhance data integrity versus typical retrospective registries.
Regulatory update
DEKRA‑based CE‑mark approval updated the VARIPULSE Catheter IFU to allow ablation outside the pulmonary veins in Europe and enable workflows for persistent AF; U.S. indications remain limited to paroxysmal AF.
Presentation and publication
Findings were presented at the PFA Summit during EHRA 2026 in Paris and published in Europace.
Source: J&J