FDA Approves Abbott Volt Pulsed Field Ablation System for Treatment of Atrial Fibrillation

The US FDA has approved Abbott’s Volt Pulsed Field Ablation (PFA) System for the treatment of patients with atrial fibrillation, the company announced December 22, 2025. The approval expands available catheter-based ablation options for both paroxysmal and persistent atrial fibrillation and supports Abbott’s planned commercial rollout of the system in the US.

Abbott reported that the Volt PFA System is indicated for patients with atrial fibrillation who require minimally invasive cardiac ablation when medication and other treatment options are insufficient. Pulsed field ablation uses high-energy electrical pulses delivered to targeted areas of myocardial tissue to interrupt abnormal electrical signaling while aiming to minimize injury to surrounding structures.

FDA approval was based on results from the VOLT-AF Investigational Device Exemption study, which enrolled 392 patients across 40 centers in the United States, Europe, Canada, and Australia. According to Abbott, the trial demonstrated clinically meaningful safety and effectiveness outcomes in patients with paroxysmal atrial fibrillation as well as those with persistent atrial fibrillation.

“Atrial fibrillation is a progressive condition where timely intervention is critical to disease management and, ultimately, the patient’s quality of life,” said DJ Lakkireddy, MD, executive medical director of the Kansas City Heart Rhythm Institute, in the company’s release. He noted that the system’s design features aim to support tissue contact and focused energy delivery during ablation procedures.

The Volt PFA System is designed as an all-in-one catheter that allows physicians to map, pace, and ablate using a single device. Abbott stated that the system incorporates a proprietary balloon-in-basket design intended to improve handling and enable efficient energy transfer to targeted tissue. The system also integrates with Abbott’s EnSite X electrophysiology mapping system to provide three-dimensional cardiac mapping and reduce the need for multiple catheter exchanges during procedures.

According to Abbott, the Volt system is designed to require a minimal number of therapy applications while supporting durable lesion formation. The company reported that the system may reduce procedure time, fluoroscopy exposure, and hemolysis compared with some existing approaches. Abbott also stated that the system allows certain patients to undergo ablation under conscious sedation rather than general anesthesia, which may be relevant for patients for whom anesthesia presents a barrier to care.

“We heard the physician feedback that patients need an alternative to general anesthesia during a PFA ablation procedure that doesn’t sacrifice strong outcomes,” said Christopher Piorkowski, MD, chief medical officer of Abbott’s electrophysiology business.

Abbott plans to begin commercial use of the Volt PFA System in the United States and continue expanding its availability in the European Union, where the system received CE Mark approval earlier in 2025.

Reference: Abbott's Volt™ Pulsed Field Ablation System Receives FDA Approval to Treat Patients with Atrial Fibrillation. News release. Abbott. https://abbott.mediaroom.com/2025-12-22-Abbotts-Volt-TM-Pulsed-Field-Ablation-System-Receives-FDA-Approval-to-Treat-Patients-with-Atrial-Fibrillation