Johnson & Johnson MedTech announced breakthrough results from the VARIPURE substudy of SECURE, demonstrating exceptional safety and effectiveness of its VARIPULSE Platform for treating atrial fibrillation through pulsed field ablation. The real-world data, presented at the 2025 European Society of Cardiology Congress in Madrid, showed zero strokes and a 99.7% acute effectiveness rate among 791 enrolled patients.
Strong Safety Profile with Zero Major Complications
The VARIPURE substudy reported a remarkably low 0.6% primary adverse event rate with no incidence of stroke, coronary spasm, or other pulsed field ablation-related complications. This safety profile was observed across 20 European centers involving 62 operators, demonstrating the platform's consistent application and adaptability across varying procedural workflows.
"An overall 0.6 percent primary adverse event rate with no strokes, coronary spasm, or other PFA-related complications demonstrates a favorable safety profile when using the VARIPULSE Platform," said Alexandre Almorad, M.D., Cardiac Electrophysiologist and Director of the Arrhythmia Unit at Brussels University Hospital St Pierre. "These outcomes, observed in nearly 800 patients across varying procedural workflows, demonstrate the platform's consistent application and adaptability in this study."
High Acute Effectiveness Across Multiple Centers
The study achieved a 99.7% acute pulmonary vein isolation rate alongside high adherence to the recommended ablation workflow. This effectiveness was maintained across diverse procedural approaches, reinforcing the platform's ability to deliver durable lesion sets consistently.
The VARIPULSE Platform consists of the VARIPULSE Catheter and TRUPULSE Generator, which seamlessly integrates with the CARTO 3 System to enable an efficient and reproducible workflow that enhances treatment and optimizes outcomes for atrial fibrillation.
Complementary Real-World Evidence
Johnson & Johnson MedTech also presented additional real-world evidence from the REAL AF Registry, a collaboration across 70 sites in the US and Canada. The analysis included 200 patients with diverse clinical profiles under different workflows using the VARIPULSE Platform, with nearly 80% of procedures completed with the 30mL irrigation flow rate. No strokes, deaths, or device-related hospitalizations were reported, with only one minor event that was deemed procedure-related, not device-related.
Study Design and Quality Standards
VARIPURE, a substudy of SECURE, is a prospective, observational, multicenter postmarket follow-up study conducted across Europe, Middle East, and Africa. The study was designed to systematically assess the safety and performance of pulsed field ablation using the VARIPULSE Platform in routine clinical practice.
The study employed rigorous methodology with patients consenting prior to procedures and all patient data collected through electronic data capture, ensuring a higher level of scientific quality compared to retrospective data collection. This approach included meticulous monitoring and data cleaning, alongside diligent oversight of safety data collection and review.
Expanding Clinical Evidence Base
"Johnson & Johnson 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, Ph.D., Vice President, Scientific Affairs, Electrophysiology, Johnson & Johnson MedTech. "Through growing registries and collaborative studies with electrophysiologists in everyday practice settings, we're building the clinical foundation that empowers physicians to optimize patient outcomes and establish a new standard of care in cardiac ablation."
The consistency and scale of these results reinforce pulsed field ablation as a transformative option for atrial fibrillation care, illustrating how the VARIPULSE Platform's safety, efficacy, and reproducibility are reshaping everyday clinical practice. The VARIPULSE Platform is now approved for use in the United States, Europe, Asia Pacific, Canada, and Latin America.
