Biosense Webster Submits Application to U.S. FDA Seeking Approval of the VARIPULSE Platform for the Treatment of Paroxysmal Atrial Fibrillation
March 28, 2024 — Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson MedTechi, announced the submission of the VARIPULSE Platform for Premarket Approval Application (PMA) to the U.S. Food & Drug Administration (FDA). The submission was supported by results from the admIRE study, a prospective, multi-center, non-randomized trial. The VARIPULSE Platform is comprised of the VARIPULSE Catheter, a fully integrated variable-loop multielectrode catheter; the TRUPULSE Generator, a pulsed field ablation (PFA) generator; and the CARTO 3 System VARIPULSE Software, which provides full integration with the world’s leading 3D cardiac mapping system. The VARIPULSE Platform is designed to enable pulmonary vein isolation with the versatility of a catheter loop, a simple generator user interface, and a mapping system that provides an intuitive, reproducible workflow with real-time visualization, contact indicator, and PF tagging mechanisms. “The VARIPULS