Abbott (ABT) Wins FDA Approval for Volt PFA System in AFib Treatment

Core Insights - Abbott Laboratories has received FDA approval for its Volt™ PFA System to treat atrial fibrillation (AFib), marking a significant advancement in its product offerings [2][4] - The Volt PFA System is expected to be commercially available in the U.S. soon, with plans for expansion in the European Union following prior CE Mark approval [2] - AFib affects approximately 12 million people in the U.S. over the age of 65, with projections indicating this number could double in the next 20 years, highlighting a growing market for treatment options [3] FDA Approval and Clinical Study - The FDA approval was based on the VOLT-AF IDE study, which included 392 patients across 40 centers in the U.S., Europe, Canada, and Australia [4] - The study demonstrated that the Volt PFA System provided clinically meaningful safety and effectiveness for patients with both paroxysmal and persistent AFib [4] Company Overview - Abbott Laboratories is recognized as a global healthcare leader, offering a diverse portfolio that includes diagnostics, medical devices, nutritionals, and branded generic medicines [5]