Abbott Receives CE Mark for its Volt™ Pulsed Field Ablation System to Treat Patients with Abnormal Heart Rhythms

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]