• Data collected over a year from the Volt CE Mark Study indicate positive outcomes for patients treated with the Volt PFA System, a pulsed field ablation (PFA) therapy.
• The Volt CE Mark Study’s one-year findings support the Volt PFA System’s enduring safety and effectiveness.
• The 2025 Heart Rhythm Society (HRS) annual meeting featured the data presentation.

ABBOTT PARK, Ill., April 27, 2025 — Abbott (NYSE: ABT) has revealed new data from its Volt CE Mark Study, demonstrating strong safety and effectiveness over 12 months for individuals with atrial fibrillation (AFib) who underwent pulsed field ablation (PFA) using the Volt PFA System. The data also emphasize the Volt PFA System’s exceptional safety profile and its capacity to produce results with fewer applications (an average of just 4.7 applications per vein) compared to currently available PFA systems.

Unlike conventional cardiac ablation methods, PFA therapy uses brief, intense electrical pulses to specific regions of heart tissue responsible for abnormal rhythms. Abbott’s Volt CE Mark Study was designed to evaluate the Volt PFA System’s impact on two distinct patient populations: those experiencing paroxysmal atrial fibrillation (PAF), characterized by intermittent episodes, and those with persistent AFib (PersAF), where episodes last longer than seven days.

The Volt CE Mark Study’s 12-month data were presented at the Heart Rhythm Society (HRS) annual meeting in San Diego (April 24-27, 2025) and simultaneously published in *Heart Rhythm*, the Heart Rhythm Society’s official journal.

Sustained Performance of the Volt PFA System
Data from the Volt CE Mark Study indicated that after a year, Abbott’s Volt PFA System achieved:

• Consistent long-term performance. The Volt PFA System maintained consistent safety and effectiveness for PAF and PersAF patients over 12 months.
• Absence of arrhythmia. After 12 months, 83.5% of PAF patients and 58.1% of PersAF patients remained free from atrial arrhythmia, representing one of the lowest recurrence rates observed in a long-term PFA study for PAF patients.
• Improved quality of life (QoL). The Volt CE Mark Study revealed a significant improvement in patients’ QoL after 12 months, with assessment scores rising from 64.1 to 88.1.
• Excellent safety record. Only 2.7% of Volt patients experienced a primary safety endpoint event after 12 months, with no instances of hemolysis (red blood cell destruction), coronary artery spasm, pulmonary vein stenosis, acute kidney injury, or phrenic nerve injury—all potential complications of PFA therapy.

According to Prof. Gian-Battista Chierchia, director of the Atrial Fibrillation Program at the Heart Rhythm Management Institute at the University of Brussels in Belgium, the Volt CE Mark Study’s 12-month results depict a PFA system with exceptional performance in two patient groups with distinct therapy needs and clinical approaches. He added that the long-term data offer a strong indication of the Volt PFA System’s clinical performance as PFA therapy is utilized for patients.

Clinical experience following CE Mark has reinforced the Volt PFA System’s ability to treat patients with either PAF or PersAF, making it a versatile solution for a wide range of patients. The Volt PFA System also offers a single-catheter PFA approach, streamlining workflow and enabling procedural flexibility through light sedation or general anesthesia. A new sub-analysis from the VOLT-AF IDE Study, presented at HRS 2025, showed comparable safety and acute effectiveness outcomes in procedures performed under conscious or deep sedation versus those performed with general anesthesia.

Christopher Piorkowski, M.D., chief medical officer of Abbott’s electrophysiology business, stated that the goal from the outset was to create a PFA system that delivers outstanding results for patients facing various atrial arrhythmias, and the Volt CE Mark Study’s latest data confirm the system’s positive impact on patient care.

About the Volt CE Mark Study
Abbott’s Volt CE Mark Study is a prospective, single-arm, non-randomized, multicenter study evaluating the safety and effectiveness of the Volt PFA System for treating symptomatic, recurrent, drug-refractory PAF and PersAF. The study enrolled 150 patients across 11 European sites and included a feasibility sub-study with additional imaging assessments to confirm the Volt PFA System’s acute safety.

About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

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