Core Insights - Abbott has announced strong safety and efficacy data from its Volt CE Mark Study for the Volt™ PFA System, demonstrating positive results for patients with atrial fibrillation (AFib) over a 12-month period [1][6] Group 1: Study Findings - The Volt CE Mark Study showed that the Volt PFA System achieved an average of 4.7 therapy applications per vein, which is fewer than competitive PFA systems [1] - After 12 months, 83.5% of patients with paroxysmal atrial fibrillation (PAF) and 58.1% of patients with persistent AFib (PersAF) remained free from atrial arrhythmia, indicating one of the lowest recurrence rates in long-term PFA studies [7] - Quality of life (QoL) scores improved significantly from 64.1 to 88.1 after 12 months of treatment [7] Group 2: Safety Profile - The Volt PFA System demonstrated an excellent safety profile, with only 2.7% of patients experiencing a primary safety endpoint event, and no cases of hemolysis, coronary artery spasm, pulmonary vein stenosis, acute kidney injury, or phrenic nerve injury reported [7] - The study confirmed that the Volt PFA System can effectively treat both PAF and PersAF patients, enhancing procedural flexibility with options for light sedation or general anesthesia [4][8] Group 3: Study Design - The Volt CE Mark Study is a prospective, single-arm, non-randomized, multicenter study that enrolled 150 patients across 11 sites in Europe, focusing on symptomatic, recurrent, drug-refractory PAF and PersAF [8]

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]