Abbott's Volt™ Pulsed Field Ablation System Receives FDA Approval to Treat Patients with Atrial Fibrillation

Core Insights - Abbott has received FDA approval for its Volt PFA System to treat atrial fibrillation (AFib), with plans to begin commercial cases in the U.S. and expand in the EU following earlier CE Mark approval [1][2] - Approximately 12 million people in the U.S. over the age of 65 have AFib, a number expected to double in the next 20 years, highlighting the growing need for effective treatment options [1] - The Volt PFA System demonstrated strong safety and effectiveness in the VOLT-AF IDE study, which included 392 patients across multiple countries [2] Product Features - The Volt PFA System is designed to simplify AFib treatment by allowing physicians to map, pace, and ablate using a single catheter, enhancing workflow and efficiency [4][5] - Its unique balloon-in-basket design provides superior tissue contact and energy delivery, addressing limitations of earlier PFA systems [3][4] - The system allows for fewer therapy applications, which can lead to better patient outcomes and reduced risk of complications [7] Clinical Benefits - The Volt PFA System supports conscious sedation instead of general anesthesia, which can facilitate faster recovery times for patients undergoing ablation procedures [7][8] - It reduces exposure to radiation and minimizes hemolysis, making it a safer option for patients [7] - The system is clinically proven to achieve durable lesions with fewer pulses, enhancing the effectiveness of first-time procedures [6][7]