The regulatory nod brings Abbott Volt to the U.S. PFA market to compete against the likes of Medtronic, Boston Scientific, Johnson & Johnson MedTech and Kardium. It follows CE mark approval for Volt earlier this year.

Abbott said it plans to begin commercial PFA cases with Volt in the U.S. soon and continue expanding across Europe, too. Approval in the U.S. came on the back of strong data from the VOLT-AF IDE study, which evaluated 392 patients across 40 centers in the U.S., Europe, Canada and Australia. The study demonstrated clinically meaningful performance from Volt in both safety and effectiveness for paroxysmal AFib (PAF) and persistent AFib (PersAF).