Johnson & Johnson’s VARIPULSE Platform Shows Exceptional 12-Month Results in Massive Real-World Study

At the 2026 European Heart Rhythm Association (EHRA) Annual Meeting, Johnson & Johnson MedTech unveiled groundbreaking 12-month interim data from its VARIPURE study. The results solidify the VARIPULSE Platform as a leading force in Pulsed Field Ablation (PFA) for patients suffering from Atrial Fibrillation (AFib).

Simultaneously published in Europace, the study represents the largest prospective post-market evaluation of its kind, involving over 1,000 patients across 22 European centers.

Clinical Highlights: Effectiveness and Safety

The interim analysis, which followed 442 patients through a full year, demonstrated that the VARIPULSE system delivers high success rates with an industry-leading safety profile.

Metric	Outcome
Overall Success Rate	84.2% freedom from atrial arrhythmia recurrence.
Paroxysmal AFib Success	90.5% effectiveness.
Persistent AFib Success	75.3% effectiveness.
Primary Adverse Events	Ultra-low 0.8% rate.
PFA-Specific Complications	Zero reported strokes or coronary spasms.

Platform Versatility & Regulatory Milestone

A standout feature of the VARIPURE data was the platform’s performance beyond standard procedures. Nearly 30% of patients received ablation outside the pulmonary veins, proving the system’s flexibility for complex cases.

Coinciding with this data, Johnson & Johnson announced CE-mark approval to update the Instructions for Use (IFU) for the VARIPULSE Catheter in Europe. This regulatory green light officially allows:

Ablation outside the pulmonary veins.
Enhanced workflows specifically designed for persistent AFib patients.

“VARIPURE represents a significant step forward… demonstrating strong results in a real-world clinical setting. The observations in persistent AFib patients speak to the platform’s versatility across a wide range of patient types.”

— Dr. Gregory Michaud, Chief Medical and Scientific Officer, Johnson & Johnson.

Why the VARIPURE Study is Different

Unlike many retrospective “look-back” registries, VARIPURE is a prospective study. This means patients consented before their procedures, and data was collected and cleaned in real-time. This rigorous scientific approach ensures a higher level of data integrity and accuracy regarding how the technology performs in everyday hospital settings.

The VARIPULSE Platform remains the only PFA system fully integrated with the CARTO 3 Mapping System, providing electrophysiologists with unmatched visualization during complex heart procedures.