Johnson & Johnson MedTech Reveals Positive Varipulse Data

Johnson & Johnson MedTech 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 (AFib).

The real-world study was presented at this year’s European Society of Cardiology (ESC) Congress. The real-world data showed that within the 791 patients included in the analysis there was a 0.6% primary adverse rate with no strokes, along with a 99.7% acute pulmonary vein isolation (PVI) and high adherence to the recommended ablation workflow.

The prospective, observational, post-market study evaluated index AFib ablations performed with Varipulse. The platform consists of the Varipulse catheter and Trupulse generator, which integrates with the Carto 3 system.

Alexandre Almorad, MD, 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, said an overall 0.6% primary adverse rate with no strokes, coronary spasm, or other PFA-related complications demonstrates a favorable safety profile when using Varipulse.

“These outcomes, observed in nearly 800 patients across varying procedural workflows, demonstrate the platform’s consistent application and adaptability in this study,” Dr. Almorad told the press. “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.”

Johnson & Johnson MedTech also recently highlights new real-world evidence at Kansas City HRS from the company-funded REAL AF registry. The REAL AF analysis included 200 diverse clinical profiles under different workflows using Varipulse, with almost 80% of the procedures completed with the 30 mL irrigation flow rate. No strokes, deaths, or device-related hospitalizations were reported.

“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.”