Sept. 2, 2025 — Johnson & Johnson MedTech has announced acute safety and effectiveness results from the Varipure substudy of SECURE, evaluating the Varipulse Platform in pulsed field ablation (PFA) procedures for atrial fibrillation (AF). The real-world data, presented at the 2025 European Society of Cardiology (ESC) Congress in Madrid, demonstrated a strong safety profile, high acute effectiveness and procedural efficiency within the 791 patients included in this analysis: notably, a 0.6% primary adverse rate with no strokes was reported along with 99.7% acute PVI and high adherence to the recommended ablation workflow.i
Varipure, a SECURE substudy, is a prospective, observational, post-market study conducted across 20 European centers, including 62 operators, that evaluated acute safety, effectiveness, and procedural characteristics of index AF ablations performed with the Varipulse Platform.i The Varipulse Platform consists of the Varipulse Catheter and Trupulse Generator, which seamlessly integrates with the Carto 3 System and enables an efficient and reproducible workflow that enhances treatment and optimizes outcomes for AF.ii,iii,iv
"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 safelyi," said Alexandre Almorad*, M.D., Cardiac Electrophysiologist, Director of the Arrhythmia Unit at Brussels University Hospital St Pierre and at the Brussels Heart Rhythm Management Center, the study presenting author.
The consistency and scale of these results reinforce PFA as a transformative option for AF care, illustrating how the Varipulse Platform's safety, efficacy, and reproducibility are already reshaping everyday clinical practice.
In addition to Varipure, Johnson & Johnson MedTech recently highlighted at Kansas City HRS new real-world evidence regarding the Varipulse Platform from the company funded REAL AF Registry—a collaboration across 70 sites in the US and Canada. The REAL AF analysis included 200 diverse clinical profiles under different workflows using the Varipulse Platform, with nearly 80% of these procedures completed with the 30mL irrigation flow rate. No strokes, deaths, or device-related hospitalizations were reported, and only one minor event occurred that was deemed procedure-, not device-related.v
"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."
Johnson & Johnson MedTech will continue collaborating with the clinical community to expand real-world evidence around the Varipulse Platform and accelerate patient-centered innovation in atrial fibrillation care.
Learn more about Johnson & Johnson's MedTech sector's global scale and deep expertise in surgery, orthopaedics,vision, and cardiovascular solutions at https://thenext.jnjmedtech.com.
i Almorad A, Sebag FS, Brix Kronborg M, et al. Acute safety, effectiveness and procedural workflow for the pulsed field ablation variable loop circular catheter in AF procedures: a prospective, multicenter, post-market clinical trial. Presented at: European Society of Cardiology (ESC) Congress; September 1, 2025; Madrid, Spain.
ii Di Biase L, Marazzato J, Gomez T, et al. Application Repetition and Electrode-Tissue-Contact Results in Deeper Lesions Using a Pulsed-Field Ablation Circular Variable Loop Catheter. Europace. Published online August 16, 2024. Page 3, paragraph 2, Results Section
iii Duytschaever M, De Potter T, Grimaldi M, et al. Paroxysmal Atrial Fibrillation Ablation Using a Novel Variable-Loop Biphasic Pulsed Field Ablation Catheter Integrated With a 3-Dimensional Mapping System: 1-Year Outcomes of the Multicenter inspIRE Study. Circ Arrhythm Electrophysiol. 2023 Mar;16(3):e011780. Page 5, Column 1, paragraph 1
iv Reddy VY, Calkins H, Mansour M, et al. Pulsed field ablation to treat paroxysmal atrial fibrillation: safety and effectiveness in the admIRE pivotal trial. Circulation. Published online September 11, 2024. doi: 10.1161/CIRCULATIONAHA.124.070333.Page 5, paragraph 2, Procedural Data Section
v Porterfield C, Krishnan K, Saleem M, Steckman D, Ebinger M, Gampa A, et al. Real-world safety profile of a multi-electrode variable loop pulsed-field ablation catheter. Presented at: Kansas City Heart Rhythm Symposium 2025; August 16 2025; Overland Park (Kansas City), KS.
* Dr. Almorad serves as a consultant for Johnson & Johnson but was not compensated for this announcement
March 24, 2026 
