Abbott has received U.S. Food and Drug Administration (FDA) approval for its Volt pulsed field ablation (PFA) system to treat patients suffering from atrial fibrillation (AFib).

The Volt PFA system builds on the company’s electrophysiology portfolio with a product that lets physicians map, pace, and ablate with the same catheter. Its proprietary balloon-in-basket design features various handling options and allows efficient energy transfer to the targeted tissue to stop the heart’s erratic signals, the company said.

It was engineered to integrate with Abbott’s EnSite X EP system to offer accurate 3D cardiac mapping and fewer catheter exchanges during an ablation.

The Volt PFA system helps achieve durable lesions with fewer pulses, according to Abbott. This accuracy supports effective first-time procedures, reducing the likelihood of repeat ablations and minimizing complication risk. Patients can be placed under conscious sedation instead of general anesthesia, and the system reduces exposure to radiation and limits breakdown of red blood cells.

“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.”

The system earned CE mark certification in March 2025.

Data supporting the Volt PFA system’s FDA approval

The company’s VOLT-AF IDE study evaluated 392 patients at 40 centers in the U.S., Europe, Canada and Australia. Data showed the system demonstrated clinically meaningful performance in both safety and effectiveness for two patient groups: paroxysmal atrial fibrillation (PAF) and persistent AFib.

“AFib is a progressive condition where timely intervention is critical to disease management and, ultimately, the patient’s quality of life. When I perform a cardiac ablation, I look for a tool with an excellent patient safety profile that can simplify the treatment of AFib,” said DJ Lakkireddy, MD, executive medical director of the Kansas City Heart Rhythm Institute and one of the first physicians to use Volt in the United States. “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.”