New Clinical Study Data Showcase Long-Term, Sustained Benefits of Abbott's Volt™ PFA System for Patients with AFib USA - English USA - English
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* Long ~ New Data from Abbott's Volt CE Mark Study Shows Strong Safety and Efficacy for Pulsed Field Ablation Therapy in Atrial Fibrillation Patients

Abbott (NYSE: ABT) has recently released new data from its Volt CE Mark Study, showcasing the strong safety and efficacy of its Volt™ PFA System for the treatment of atrial fibrillation (AFib). The study, presented at the 2025 Heart Rhythm Society (HRS) annual meeting in San Diego and published in Heart Rhythm, the official journal of HRS, highlights the excellent performance of the Volt PFA System in both safety and effectiveness out to 12 months.

Pulsed field ablation (PFA) therapy is a unique approach to treating AFib that delivers high energy electrical pulses to targeted areas of cardiac tissue. Unlike traditional cardiac ablation methods, PFA has shown promising results in achieving freedom from arrhythmia with fewer therapy applications. Abbott designed its Volt CE Mark Study to assess the impact of the Volt PFA System on two different patient groups – those with paroxysmal atrial fibrillation (PAF) and those with persistent AFib (PersAF).

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After 12 months, data from the study showed that the Volt PFA System delivered outstanding long-term performance in both safety and effectiveness for patients with PAF and PersAF. In fact, 83.5% of PAF patients and 58.1% of PersAF patients remained free from atrial arrhythmia after 12 months – one of the lowest rates of reoccurrence in a long-term PFA study to date.

The study also revealed significant quality of life benefits for patients after 12 months, with QoL assessment scores improving from 64.1 to 88.1. Additionally, the Volt PFA System demonstrated an excellent safety profile with just 2.7% of patients experiencing a primary safety endpoint event. None of the patients suffered from hemolysis, coronary artery spasm, pulmonary vein stenosis, acute kidney injury, or phrenic nerve injury – all potential challenges of PFA therapy.

Prof. Gian-Battista Chierchia, director of the Atrial Fibrillation Program at the Heart Rhythm Management Institute at the University of Brussels in Belgium, commented on the study's results, stating 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 – each with unique therapy needs and clinical approaches."

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The Volt PFA System has also shown to be effective in treating both PAF and PersAF patients in clinical settings following CE Mark approval. The system's single-catheter approach improves workflow and provides procedural flexibility by allowing for light sedation or general anesthesia. A new sub-analysis from the VOLT-AF IDE Study presented at HRS 2025 showed no significant difference in safety or acute effectiveness outcomes between procedures performed under conscious or deep sedation compared to those performed with general anesthesia.

Christopher Piorkowski, M.D., chief medical officer of Abbott's electrophysiology business, expressed his satisfaction with the study's results, stating that "our goal from the beginning with the Volt PFA System was to design a system that would provide outstanding results in patients battling a range of atrial arrhythmias." He believes that these latest data from the Volt CE Mark Study confirm that their system will have a positive impact on patient care.

In conclusion, Abbott's Volt CE Mark Study has shown strong evidence for the safety and efficacy of its Volt PFA System in treating AFib patients. With its excellent performance and ability to treat both PAF and PersAF patients, this system has the potential to revolutionize AFib treatment and improve patient outcomes.
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