The Volt CE Mark study evaluated Volt’s safety and efficacy out to 12 months for treating AFib. Data highlighted the system’s safety profile along with its ability to achieve results with fewer therapy applications (4.7 applications per vein on average) than on-market, competitive PFA systems. Abbott aims to enter the PFA market alongside the likes of Boston Scientific (Farapulse), Medtronic (PulseSelect and Affera), and Johnson & Johnson MedTech (Varipulse). The company already has CE mark for Volt, beginning its European rollout last month.
Volt provides a single-catheter PFA approach to improve workflow and provide procedural flexibility. The company designed Volt to address the limitations of existing PFA technologies. It paired a balloon-in-basket catheter with the EnSite X EP heart mapping system. Ensite X helps physicians visualize and position tools like the Volt PFA catheter in the heart.
It features electrodes that only face outward with flat, not round, insulated nitinol splines. This further maximizes efficient energy transfer into the heart tissue. (Read more about Volt at MDO.)
Abbott designed its study to assess the impact of Volt in two different patient groups: paroxysmal AFib (PAF) and persistent AFib (PersAF). The company presented its 12-month data at the 2025 Heart Rhythm Society (HRS) annual meeting in San Diego.
“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 Dr. Christopher Piorkowski, chief medical officer of Abbott’s electrophysiology business.
A look at the Abbott Volt PFA study results
Abbott’s study looked at Volt in treating symptomatic, recurrent, drug-refractory PAF and PersAF. It enrolled 150 patients across 11 sites in Europe and included a feasibility sub-study. In the sub-study, investigators collected additional imaging assessments to confirm the acute safety of Volt.
The study delivered evidence of strong long-term performance for the Volt PFA system. It demonstrated sustained performance in safety and effectiveness at 12 months for both PAF and PersAF patients. Additionally, 83.5% of PAF patients and 58.1% of PersAF patients remained free from atrial arrhythmia after 12 months. Abbott said this marks one of the lowest rates of reoccurrence in PAF patients in a long-term PFA study.
Additionally, the company reported improved quality of life (QoL) with Volt. QoL assessment scores improved from 64.1 to 88.1. And, after a year, just 2.7% of Volt patients experienced a primary safety endpoint event. Zero patients suffered from hemolysis (destruction of red blood cells), coronary artery spasm, pulmonary vein stenosis, acute kidney injury, or phrenic nerve injury – all potential challenges of PFA therapy.
“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 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.”
