Johnson & Johnson MedTech has released new data from the VARIPURE substudy of SECURE, a real-world evaluation of its VARIPULSE Platform for pulsed field ablation (PFA) in atrial fibrillation (AF) treatment. The results were presented at the 2025 European Society of Cardiology Congress in Madrid.
The analysis covered 791 patients across 20 European centers and included input from 62 operators. Findings showed a primary adverse event rate of 0.6% with no reported strokes, as well as a 99.7% acute pulmonary vein isolation (PVI) rate. High adherence to recommended ablation workflows was also observed.
“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. 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 percent 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,” said Alexandre Almorad1, M.D., Cardiac Electrophysiologist, Director of the Arrhythmia Unit at Brussels University Hospital St Pierre and at the Brussels Heart Rhythm Management Center, who presented the study findings.
The VARIPURE substudy is prospective and observational, conducted after market approval across Europe, Middle East, and Africa. It aims to systematically assess safety and performance of PFA using VARIPULSE in standard clinical practice by enrolling patients before procedures and collecting data electronically under close monitoring.
In addition to these findings from Europe, Johnson & Johnson MedTech also shared recent real-world evidence from the REAL AF Registry—a collaboration involving 70 sites in the United States and Canada—at Kansas City HRS. This registry included data from over 200 cases using different procedural workflows with nearly four out of five procedures performed at a specific irrigation flow rate. No strokes or deaths were reported; only one minor event occurred that was related to procedure rather than device.
“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 at 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 company stated it will continue collaborating with clinicians to expand real-world evidence on VARIPULSE and support innovation in AF care.
The VARIPULSE Platform integrates catheter technology with mapping systems designed for efficient workflow during cardiac ablation procedures. The system has been approved for use not only in Europe but also in North America (United States and Canada), Asia Pacific regions, and Latin America.
Johnson & Johnson describes itself as addressing significant unmet needs through advanced cardiovascular technologies such as mapping systems for heart rhythm disorders including AF—one of several conditions contributing significantly to global morbidity according to industry reports (https://thenext.jnjmedtech.com).
Cautionary statements were included regarding forward-looking information about product performance due to possible risks associated with research development timelines or regulatory approvals.
For more details about their cardiovascular solutions portfolio or further updates on their MedTech sector’s work worldwide visit https://thenext.jnjmedtech.com.