Abbott (ABT) announced on Monday that the U.S. Food and Drug Administration has approved its Volt Pulsed Field Ablation (PFA) system for treating atrial fibrillation, paving the way for commercial use of the device in the United States.
The approval follows results from Abbott's VOLT-AF IDE trial, which enrolled 392 patients across 40 centers in the U.S., Europe, Canada, and Australia. The study showed the Volt system met key safety and effectiveness goals in patients with both paroxysmal atrial fibrillation, where episodes come and go, and persistent atrial fibrillation, where episodes last longer than seven days.
Atrial fibrillation affects an estimated 12 million Americans over age 65, a figure expected to double over the next two decades. The condition significantly raises the risk of stroke and is often treated with catheter-based ablation when medications fail.
Abbott said the Volt system is designed to simplify ablation procedures by allowing physicians to map, pace, and ablate using a single catheter. The system integrates with the company's EnSite X mapping platform, potentially reducing procedure time and the need for multiple catheter exchanges.
Physicians can also perform procedures using conscious sedation instead of general anesthesia, which Abbott says may shorten recovery times and expand treatment options for more patients. The company plans to begin U.S. commercial cases soon and continue expanding use in Europe following earlier CE Mark approval.
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