FDA Approves Abbott's Volt PFA System for AFib
CONFIRMED84% CONFIDENCEThe release is datelined "ABBOTT PARK, Ill., Dec. 22, 2025" and says Abbott "today announced" the FDA[5] has approved the Volt PFA System (the FDA's own record gives a decision date of 12/19/2025).
The FDA approved Abbott's Volt pulsed field ablation system, a balloon-in-basket catheter that maps, paces and ablates, to treat paroxysmal and persistent atrial fibrillation. The approval rested on the 392-patient VOLT-AF IDE study at 40 centers.
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