By: IPP Bureau
Last updated : December 24, 2025 8:24 pm
AFib is a progressive condition where timely intervention is critical to disease management and, ultimately, the patient's quality of life
In what promises new hope for AFib patients, global pharma giant Abbott has announced that the US FDA has approved its Volt PFA System for treating patients with the condition.
Atrial fibrillation (AFib) affects roughly 12 million Americans over 65. With FDA approval in hand, Abbott is poised to bring a new standard of care to AFib patients across the US, offering safer, faster, and more precise treatment for the condition.
The company plans to begin commercial PFA procedures in the US immediately, while continuing to expand in Europe following CE Mark approval earlier this year.
AFib patients face a fivefold increased risk of stroke, and the condition has been linked to thousands of deaths over the past two decades. When medications fail, many turn to minimally invasive cardiac ablation to correct irregular heart rhythms.
“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, executive medical director of the Kansas City Heart Rhythm Institute and one of the first US physicians to use Volt.
“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.”
FDA clearance was based on data from Abbott’s VOLT-AF IDE study, which tracked 392 patients across 40 centers worldwide. The system showed strong safety and effectiveness for both paroxysmal AFib (PAF) and persistent AFib (PersAF).
The Volt PFA System allows doctors to map, pace, and ablate with a single catheter, incorporating feedback from physicians to improve ease of use and efficiency. Its balloon-in-basket design delivers energy directly to targeted tissue while integrating with Abbott’s EnSite X EP System for precise 3D cardiac mapping.
The system is designed to minimize therapy applications, reduce the need for catheter repositioning, and enhance patient outcomes. Patients may also undergo procedures under conscious sedation rather than general anesthesia, lowering risks and shortening recovery times.
“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, 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.”