Volt Pulsed-Field Ablation System Gains FDA Approval

The Volt pulsed-field ablation (PFA) system (Abbott) has been approved by the US Food and Drug Administration for the treatment of patients with atrial fibrillation (AF), according to a Monday announcement by device maker Abbott.

The FDA’s decision was based on positive results from the VOLT-AF IDE trial, which were presented last month at the Asia Pacific Heart Rhythm Society’s annual scientific session. The study showed that in patients with symptomatic, recurrent, drug-refractory AF, 93.1% of those with paroxysmal AF and 81.9% of those with persistent AF were free from documented arrhythmia recurrence at 6 months. The rate of the primary safety endpoint (a composite of device- and/or procedure-related serious adverse events within 7 days of ablation) was 1.9%.

“Volt is a promising option for patients. Its real-time contact visualization and unique balloon-in-basket design provide superior tissue contact and focused energy delivery, while addressing some of the limitations of the early-generation PFA systems,” Dhanunjaya Lakkireddy, MD (Kansas City Heart Rhythm Institute, Overland Park, KS), said in the Abbott press release.

The company said commercial cases with the Volt catheter will begin soon in the United States, where it joins several competing PFA devices. Its use continues to expand in Europe, where the device received CE Mark approval in March. That approval was based on the results of the VOLT CE Mark study, which were reported in April.