New Data Backs Abbott’s Volt Pulsed Field Ablation System

Abbott released new data from its Volt CE mark study that shows strong safety and efficacy at 12-months for pulsed field ablation (PFA) with its Volt PFA to treat atrial fibrillation (AFib).

The company designed the CE mark study to evaluate impact of Volt PFA in people with paroxysmal AFib (PAF) (episodes that come and go) and persistent AFib (PersAF) (episodes that last longer than a week). The 12-month study data was presented at this year’s Heart Rhythm Society annual meeting.

The study enrolled 150 patients at 11 sites across Europe and included a feasibility study where further imaging assessments were collected to confirm Volt PFA’s acute safety.

Sustained performance in safety and effectiveness was demonstrated out to 12 month for patients with both types of AFib. 83.5% of PAF patients and 58.1% of PersAF patients remained free from atrial arrhythmia after 12 months.

Quality of life (QoL) assessment scores improved from 64.1 to 88.1 during the study’s duration. After 12 months, only 2.7% of Volt patients experienced a primary safety endpoint with no patients suffering from hemolysis, coronary artery spasm, pulmonary vein stenosis, acute kidney injury, or phrenic nerve injury.

Volt PFA also has a single-catheter PFA 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 in cases performed under conscious or deep sedation, when compared to procedures performed with general anesthesia.

“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,” said Prof. Gian-Battista Chierchia, director of the Atrial Fibrillation Program at the Heart Rhythm Management Institute at the University of Brussels in Belgium. “These long-term data provide us a strong picture of how the Volt PFA System will perform in clinical settings as we leverage PFA therapy for our patients.”

The Volt PFA system earned EU approval last month.

“Our goal from the beginning with the Volt PFA System was to design a PFA system that would provide outstanding results in patients battling a range of atrial arrhythmias, and the latest data from the Volt CE Mark Study is confirmation that the system will truly impact patient care in a positive way,” said Christopher Piorkowski, MD, chief medical officer of Abbott’s electrophysiology business.