The FDA has approved a new class of ablation device — Abbott’s Volt pulsed field ablation system — for the treatment of atrial fibrillation.
The Volt system delivers high-energy electrical pulses to targeted areas of the heart to disrupt abnormal rhythms, according to a Dec. 22 news release. It is designed to simplify ablation procedures, shorten recovery time and allow treatment under conscious sedation rather than general anesthesia.
Approval was based on results from the VOLT-AF IDE study, which enrolled 392 patients across 40 centers in the U.S., Europe, Canada and Australia. The device demonstrated safety and effectiveness in treating both paroxysmal and persistent forms of AFib.
Abbott, based in Abbott Park, Ill., plans to launch the device commercially in the U.S. and expand access in Europe, where it received CE Mark approval in early 2025.
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