Pulsed Field Ablation for Cardiac Arrhythmias: Industry Landscape and US Food and Drug Administration-approved Platforms (2025).

Abstract

Pulsed field ablation (PFA) has rapidly advanced from an experimental modality to a front-line therapy for catheter ablation of atrial fibrillation (AF). Unlike thermal approaches such as radiofrequency (RF) or cryoablation, PFA relies on irreversible electroporation, producing rapid and selective myocardial lesions with minimal risk of collateral injury. This review examines the contemporary landscape of PFA technology, with emphasis on recent United States Food and Drug Administration (FDA) approvals that have expanded PFA from single-energy, single-shot systems toward focal and hybrid ablation strategies. Particular focus is placed on FDA-approved platforms, including PulseSelect™ (Medtronic, Minneapolis, MN, USA), FARAPULSE™ (Boston Scientific, Marlborough, MA, USA), and VARIPULSE™ (Biosense Webster, Diamond Bar, CA, USA), as well as next-generation systems such as the Affera Sphere-9™ dual-energy RF-PFA platform (Medtronic) and the Volt™ focal PFA system (Abbott, Chicago, IL, USA). Differences in catheter design, energy delivery, workflow, mapping integration, regulatory labeling, and clinical outcomes are reviewed. By contextualizing these platforms within evolving ablation strategies, this review highlights a second evolutionary phase of PFA focused on procedural flexibility, lesion durability, and integration with established electrophysiology (EP) workflows, with implications for future AF management and EP lab practice.