New Clinical Study Data Showcase Long-Term, Sustained Benefits of Abbott's Volt™ PFA System for Patients with AFib

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]