Abbott’s Volt™ PFA System Earns CE Mark for Advanced AFib Treatment

Abbott announced CE Mark approval for its Volt™ Pulsed Field Ablation (PFA) System, a transformative treatment for atrial fibrillation (AFib) now available commercially in the EU. The system integrates mapping, pacing, and ablation into one catheter, enhancing safety and efficiency. Clinical trials demonstrated 99.1% pulmonary vein isolation (PVI) success—critical for stopping AFib—with significantly fewer energy applications than competitors.

The Volt PFA System’s design overcomes limitations of earlier technologies by pairing with Abbott’s EnSite™ X EP system for real-time visualization. This allows precise catheter positioning, efficient energy delivery, and flexibility in sedation options. “Volt reflects years of PFA innovation,” said Dr. Christopher Piorkowski, Abbott’s EP Chief Medical Officer. “It simplifies workflows while improving outcomes—a win for clinicians and patients.”

Abbott’s VOLT-AF IDE Study (400 patients) completed enrollment early, with 12-month data expected this year. Parallel advances include the TactiFlex™ Duo Catheter, now in late-stage trials for focal PFA, and recent U.S./EU approvals for Abbott’s Agilis™ NxT Steerable Introducer (13F), which expands compatibility with PFA therapies.