Abbott Secures FDA Approval for Volt, Enters U.S. Pulsed Field Ablation Market

Abbott has received U.S. Food and Drug Administration approval for its Volt pulsed field ablation (PFA) system, enabling the company to compete in the fast-growing U.S. market for atrial fibrillation treatments alongside Medtronic, Boston Scientific, and Johnson & Johnson.

The catheter-based Volt system treats paroxysmal and persistent atrial fibrillation by delivering targeted, high-energy electrical pulses to cardiac tissue. Pulsed field ablation is gaining popularity because it can create precise lesions while reducing the risk of damage to surrounding structures.

Abbott says Volt’s balloon-in-basket design, combined with 3D mapping integration, allows effective lesion formation with fewer pulses and may reduce complications. The system also offers the option of using conscious sedation instead of general anesthesia.

The FDA decision was based on data from a study involving 392 patients at 40 centers across the U.S., Europe, Canada, and Australia. Abbott received CE Mark approval earlier this year and plans to expand Volt’s use in both the U.S. and Europe, entering an increasingly competitive PFA landscape.

22-12-2025