Abbott’s Volt pulsed field ablation (PFA) System has nabbed FDA clearance, expanding treatment options for atrial fibrillation as PFA gains traction in cardiac care. The company plans to begin commercial cases in the U.S., following earlier CE Mark approval in Europe.

Roughly 12 million Americans over age 65 have AFib, a number expected to double in the next 20 years. The condition carries a fivefold increased risk of stroke and has contributed to deaths in the U.S. for more than two decades. When medications fail, catheter-based ablation can interrupt the abnormal electrical signals that trigger irregular heart rhythms, providing a reliable option to restore normal rhythm.

FDA approval was supported by data from Abbott’s VOLT-AF IDE study, which enrolled 392 patients across 40 centers in the U.S., Europe, Canada, and Australia. The trial included patients with paroxysmal AFib, which comes and goes, and persistent AFib, where episodes last longer than seven days. Volt demonstrated meaningful safety and effectiveness in both groups.
“AFib is a progressive condition where timely intervention is critical,” said DJ Lakkireddy, M.D., executive medical director of the Kansas City Heart Rhythm Institute and an early U.S. user of the system. He highlighted Volt’s real-time contact visualization and balloon-in-basket design, which improve tissue contact and energy delivery compared with earlier PFA technologies.

Beyond these design features, Volt combines mapping, pacing, and ablation into a single catheter. It integrates with Abbott’s EnSite X system to provide three-dimensional cardiac mapping while reducing the need for multiple catheter exchanges. The catheter also delivers targeted energy with fewer therapy applications, supporting efficient procedures and consistent results.

Another benefit: Ablations can be performed under conscious sedation rather than general anesthesia, which lowers anesthesia-related risk and makes the procedure more accessible. Plus, the system may reduce fluoroscopy exposure and limit hemolysis during procedures.

“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, M.D., chief medical officer of Abbott’s electrophysiology business. “The Volt PFA System is an option for patients who prefer conscious sedation, which can also lead to faster recovery times and shorter procedures for the millions of Americans who suffer from an abnormal heart rhythm.”

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