Johnson & Johnson MedTech (NYSE: JNJ) today announced positive safety and effectiveness results from a substudy of its Varipulse platform.
VARIPURE, a substudy of the SECURE study, evaluated Varipulse in pulsed field ablation (PFA) procedures for treating AFib. Investigators shared results at the 2025 European Society of Cardiology (ESC) Congress in Madrid.
J&J MedTech is one of three companies with FDA approval for PFA technologies, along with Boston Scientific and Medtronic, after Varipulse received an FDA nod in November 2024. Commercial activity hit a snag earlier this year when the company temporarily halted all U.S. cases using Varipulse in January. After reviewing four reported neurovascular events, the company resumed sales a month later. In July, the company picked up an updated FDA approval for the Varipulse platform.
In the VARIPURE findings presented at ESC 2025, Varipulse demonstrated a strong safety profile, high acute effectiveness and procedural efficiency in the 791 patients evaluated in the analysis. J&J MedTech notes a 0.6% primary adverse event rate with no strokes reported, plus 99.7% acute pulmonary vein isolation (PVI). Investigators reported a high adherence to the recommended ablation workflow, too.
Johnson & Johnson MedTech said the results reinforce PFA as “a transformative option for AFib care.”
“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, VP, 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.”
