April 13, 2026 — Johnson & Johnson has announced favorable 12-month interim effectiveness and safety results from Varipure, the largest prospective post-market follow-up study evaluating first-time pulsed field ablation (PFA) using the Varipulse Platform.
The data were presented at the PFA Summit during the 2026 European Heart Rhythm Association (EHRA) Annual Meeting in Paris and simultaneously published in Europace.
Key 12-month highlights include:
- High effectiveness with 84.2% freedom from all documented atrial arrhythmia recurrence at 12 months1, including 90.5% for paroxysmal patients and 75.3% for persistent patients2, based on Kaplan–Meier estimates.i
- A strong safety profile with 0.8% primary adverse event (PAE) rate and zero reported strokes, coronary spasm or other PFA-related complications.i,3
- Complete cohort includes 1,023 patients across 22 European centers. At the time of analysis, 442 patients completed 12-month follow-up.
- 29.7% of patients were treated beyond the pulmonary veins4, demonstrating Varipulse Platform versatility.
“The Varipure results adds important real-world evidence demonstrating that pulsed field ablation with the VaripulsePlatform can deliver both durable effectiveness and a consistently strong safety profile across a broad AFib populationi,” said Daniel Scherr5, M.D., Department of Cardiology, Medical University of Graz, Austria. “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 practicei.”
“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 strategiesi,” said Gregory Michaud, M.D., Chief Medical and Scientific Officer, Electrophysiology, Johnson & Johnson. “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.”
The company also announced CE-mark approval to update the Instructions for Use (IFU) of the Varipulse Catheter to allow ablation outside the pulmonary veins in Europe, following DEKRA approval based on real-world data. The change also enables workflows for the treatment of patients with persistent AFib. This reflects the growing clinical evidence supporting the technology, marking continued regulatory progress in EMEA.
Johnson & Johnson continues to grow the body of research supporting its electrophysiology portfolio, accelerating the adoption of PFA in treating AFib. Findings presented at EHRA 2026, including Varipure, reflect data-driven advancements in clinical practice that enable physicians to deliver more effective and efficient care for patients with AFib.
The Varipure Study
Varipure, a substudy of Secure, is a prospective, observational, multicenter postmarket follow-up study in Europe designed to systematically assess the safety and performance of PFA using the Varipulse Platform in routine clinical practice. By having patients consent prior to the procedure, ensuring all patient data collection through electronic data capture, implicates a higher level of scientific quality compared to retrospective data collection. This approach includes meticulous monitoring and data cleaning, alongside diligent oversight of safety data collection and review, thereby ensuring the accuracy and integrity of the dataset. This rigorous upfront monitoring is absent in most published data from PFA registries to date.
For more, visit www.jnjmedtech.com.
Footnotes
- Freedom from documented (symptomatic and asymptomatic) atrial arrythmia recurrence with episodes ≥30 seconds recorded by ECG after a 3-month blanking period
-
Varipulse is approved in the U.S. for the treatment of paroxysmal patients only
-
Patients without at least 90 days of follow-up are excluded from the safety evaluation unless they experienced a PAE
-
Varipulse in the U.S. is not indicated to use outside the pulmonary veins
-
Dr. Scherr served as a study investigator and as a consultant for Johnson & Johnson. Dr. Scherr was not compensated for this authorship contribution.
i Scherr D, Bessière F, Kronborg MB, et al; VARIPURE Investigators. Effectiveness of AF pulsed field ablation with a variable loop circular catheter: 12-month VARIPURE results. Presented at: PFA Summit: European Heart Rhythm Association (EHRA) Congress; April 11, 2025; Paris, France.
April 06, 2026 
