Abbott has received U.S. Food and Drug Administration (FDA) approval for its Volt™ Pulsed Field Ablation (PFA) System for the treatment of atrial fibrillation, a common heart rhythm disorder that affects millions of patients. The approval follows the system’s earlier CE Mark in the European Union and allows Abbott to begin commercial PFA procedures in the United States, while continuing to expand its use across international markets.
The Volt PFA System is a next‑generation cardiac ablation technology designed to treat irregular heart rhythms by delivering targeted high‑energy electrical pulses that stop erratic electrical signals in the heart. The system integrates mapping, pacing and ablation functions into a single catheter and incorporates a proprietary balloon‑in‑basket design to improve tissue contact and energy transfer to the targeted area. It is intended to simplify procedures, reduce the number of therapy applications needed and support better recovery outcomes with shorter procedure times.
FDA approval was supported by data from the VOLT‑AF IDE clinical study, which enrolled 392 patients at 40 centres in the United States, Europe, Canada and Australia. The trial demonstrated clinically meaningful performance in terms of safety and effectiveness for both paroxysmal atrial fibrillation, where episodes come and go, and persistent atrial fibrillation, where episodes last longer.
The Volt PFA System is designed to work with Abbott’s EnSite™ X EP System, providing accurate three‑dimensional cardiac mapping and requiring fewer catheter exchanges during procedures. This integration aims to enhance procedural efficiency and deliver precise, targeted energy to the heart tissue. The system also offers options for patients to undergo procedures under conscious sedation rather than general anaesthesia, potentially reducing radiation exposure and limiting red blood cell breakdown.
Abbott’s FDA approval of the Volt™ Pulsed Field Ablation System marks a significant advance in atrial fibrillation treatment, offering a safer, more efficient and minimally invasive option for millions of patients, while reinforcing Abbott’s leadership in innovative cardiac care technologies.
