Abbott has announced the 12-month results of its Volt CE Mark Study, demonstrating the safety and efficacy of the Volt PFA System for patients receiving pulsed field ablation (PFA) therapy to treat atrial fibrillation (AFib). The data, presented at the 2025 Heart Rhythm Society annual meeting in San Diego and published in the Heart Rhythm journal, highlight the system's favorable safety profile and ability to achieve results with fewer therapy applications compared to other on-market PFA systems.
The Volt CE Mark Study examined Abbott's Volt PFA System in two patient groups: those with paroxysmal atrial fibrillation (PAF), with transient episodes, and persistent AFib (PersAF), with longer episodes. The system delivered notable long-term performance, maintaining safety and effectiveness out to 12 months.
The study results showed 83.5% of PAF patients and 58.1% of PersAF patients remained free from atrial arrhythmia after 12 months. There was also a pronounced improvement in the quality of life for patients, with assessment scores rising from 64.1 to 88.1. Furthermore, only 2.7% of patients experienced primary safety endpoint events, and none experienced issues such as hemolysis or pulmonary vein stenosis.
Professor Gian-Battista Chierchia from the University of Brussels noted that "The long-term 12-month results from the Volt CE Mark Study paint a picture of a PFA system that performs exceptionally well in two different groups of patients." He added that the data provide insight into the system's clinical performance.
The Volt PFA System supports treatment for both PAF and PersAF, offering flexibility by allowing for either light sedation or general anesthesia. Dr. Christopher Piorkowski, Abbott's chief medical officer for electrophysiology, emphasized the positive impact the system is expected to have on patient care.
The Volt CE Mark Study is a prospective, single-arm, non-randomized, multicenter study that included 150 patients across 11 sites in Europe. It aims to demonstrate the safety and effectiveness of the Volt PFA System, with additional sub-studies assessing acute safety.
Abbott is a global healthcare company with a wide range of products in diagnostics, medical devices, nutritionals, and branded generic medicines, operating in over 160 countries.