Johnson & Johnson (J&J) MedTech has today announced acute safety and effectiveness results from the VARIPURE substudy of the SECURE study evaluating the company’s Varipulse platform in pulsed field ablation (PFA) procedures for atrial fibrillation (AF).
The real-world data—presented at the 2025 European Society of Cardiology (ESC) congress (29 August–1 September, Madrid, Spain)—demonstrated a strong safety profile, high acute effectiveness and procedural efficiency within the 791 patients included in this analysis. In addition, a J&J press release highlights the fact that, notably, a 0.6% primary adverse rate with no strokes was reported along with 99.7% acute pulmonary vein isolation (PVI) and high adherence to the recommended ablation workflow.
VARIPURE is a prospective, observational, post-market study conducted across 20 European centres, and including 62 operators, that evaluated acute safety, effectiveness and procedural characteristics of index AF ablations performed with Varipulse.
The Varipulse platform consists of the Varipulse catheter and Trupulse generator, which integrate with J&J’s Carto 3 system to enable an efficient and reproducible workflow that enhances treatment and optimises outcomes for AF, the company claims.
“An overall 0.6% primary adverse event rate with no strokes, coronary spasm, or other PFA-related complications, demonstrates a favourable safety profile when using the Varipulse platform,” said study presenting author Alexandre Almorad (Brussels University Hospital Saint Pierre/Brussels Heart Rhythm Management Center, Brussels, Belgium). “These outcomes, observed in nearly 800 patients across varying procedural workflows, demonstrate the platform’s consistent application and adaptability in this study. By delivering a 99.7% acute PVI rate alongside seamless integration into diverse procedural workflows, this study reinforces our ability to deliver durable lesion sets, giving electrophysiologists the confidence to adopt PFA widely and safely.”
J&J further claims that the consistency and scale of these results reinforce PFA as a “transformative” option for AF care, illustrating how the Varipulse platform’s safety, efficacy and reproducibility are “already reshaping everyday clinical practice”.
In addition to VARIPURE, J&J MedTech recently highlighted new real-world evidence at the Kansas City Heart Rhythm Symposium (KCHRS; 16–17 August, Kansas City, USA) regarding Varipulse from the company-funded REAL AF registry—a collaboration across 70 sites in the USA and Canada. The REAL AF analysis included 200 diverse clinical profiles under different workflows using the Varipulse platform, with nearly 80% of these procedures completed with a 30mL irrigation flow rate. No strokes, deaths or device-related hospitalisations were reported, and only one minor event occurred that was deemed procedure-related as opposed to device-related.
“J&J MedTech is committed to advancing the real-world evidence base for Varipulse, generating robust clinical data to demonstrate its safety and efficacy across diverse patient populations,” said Jennifer Currin, vice president, scientific affairs, electrophysiology, J&J MedTech. “Through growing registries and collaborative studies with electrophysiologists in everyday practice settings, we’re building the clinical foundation that empowers physicians to optimise patient outcomes and establish a new standard of care in cardiac ablation.”
