Varipulse, the medtech giant’s pulsed field ablation (PFA) platform, is designed to streamline ablation and mapping through a single integrated workflow with the Carto 3 mapping system. Carto 3 offers 3D heart mapping for electrophysiology procedures, including PFA. With Carto 3, Varipulse offers enhanced precision, efficiency, and procedural reproducibility for physicians treating patients with AFib.
VARIPURE, the company’s post-market follow-up study, evaluates the Varipulse PFA system in treating AFib. J&J presented early safety and effectiveness results from VARIPURE in September 2025. Now, the company reports new data, presented at the PFA Summit during the 2026 European Heart Rhythm Association (EHRA) Annual Meeting in Paris and simultaneously published in Europace.
More about the study findings
The complete cohort included 1,023 patients across 22 European centers. At the time of analysis, 442 patients completed 12-month follow-up.
Key 12-month findings include high effectiveness, with Varipulse producing 84.2% freedom from all documented atrial arrhythmia recurrence at 12 months. That included 90.5% for paroxysmal patients and 75.3% for persistent patients. The system also delivered a strong safety profile, with a 0.8% primary adverse event (PAE) rate. Investigators reported zero strokes, coronary spasm or other PFA-related complications.
Additionally, 29.7% of patients received treatment beyond the pulmonary veins, demonstrating Varipulse’s versatility, J&J said.
The positive findings come on the heels of CE mark for updates to Varipulse to allow ablation outside the pulmonary veins in Europe. J&J just last week launched an updated version of Varipulse in Europe. Varipulse competes in the hot PFA market alongside several big names in medtech. In Europe, those include Volt (Abbott), Farapulse (Boston Scientific), PulseSelect (Medtronic), Globe (Kardium), Centauri (CardioFocus) and PulseMagic (MicroPort EP).
Commentary from Johnson & Johnson officials and doctors
Dr. Gregory Michaud, chief medical and scientific officer, Electrophysiology, Johnson & Johnson, 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.”
Dr. Daniel Scherr, Department of Cardiology, Medical University of Graz, Austria, said:
“The VARIPURE results adds important real-world evidence demonstrating that pulsed field ablation with the Varipulse platform can deliver both durable effectiveness and a consistently strong safety profile across a broad AFib population. 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.”
