ABBOTT PARK, Ill., Dec. 22, 2025 /PRNewswire/ -- Abbott (NYSE: ABT) today announced the U.S. Food and Drug Administration (FDA) has approved the company's Voltâ"¢ PFA System to treat patients battling atrial fibrillation (AFib). Abbott will soon begin commercial PFA cases in the United States and will continue its expansion of sites in the European Union following Volt CE Mark approval earlier this year. 12 Minimal number of therapy applications and enhanced patient outcomes. The Volt PFA System is designed ...

Core Insights - Abbott has received CE Mark approval for the Volt™ PFA System, enabling the treatment of atrial fibrillation (AFib) in Europe, with commercial cases already initiated [1][3] - The Volt PFA System is designed to improve the workflow of cardiac ablation procedures by utilizing a single-catheter approach, which allows for mapping, pacing, and ablating simultaneously [2][8] - The Volt PFA System demonstrated a 99.1% success rate in achieving pulmonary vein isolation (PVI) during clinical trials, outperforming existing competitive systems [3][10] Company Developments - Abbott has begun commercial use of the Volt PFA System in the EU, with plans for further expansion in the second half of the year [1] - Initial cases were performed by leading physicians in various European hospitals, indicating strong clinical interest and early adoption [3][4] - The Volt PFA System is part of Abbott's broader electrophysiology portfolio, which includes ongoing clinical studies and regulatory approvals for related technologies [11][12] Market Context - Approximately 8 million Europeans over 65 are currently living with AFib, a number projected to double in the next 30 years, highlighting a significant market opportunity for effective treatment solutions [2] - The Volt PFA System addresses limitations of existing PFA systems by providing enhanced visualization and navigation capabilities, which can lead to improved patient outcomes [6][10] - The integration of the Volt PFA System with Abbott's EnSite™ X EP system enhances procedural efficiency and accuracy, positioning Abbott favorably in the competitive landscape of electrophysiology [6][9]