Abbott (NYSE: ABT) has announced promising 12-month data from its Volt CE Mark Study, showcasing the Volt™ Pulsed Field Ablation (PFA) System excellent safety profile and lasting effectiveness for patients with atrial fibrillation (AFib). The findings were presented at the 2025 Heart Rhythm Society (HRS) Annual Meeting in San Diego and published simultaneously in Heart Rhythm, the official journal of HRS.
Pulsed Field Ablation: A New Approach to AFib Treatment
Unlike traditional cardiac ablation methods, PFA therapy uses high-energy electrical pulses to target and treat abnormal cardiac tissue. Abbott specifically designed the Volt CE Mark Study to evaluate the system’s performance in two groups:
- Patients with Paroxysmal Atrial Fibrillation (PAF) – episodes that come and go.
- Patients with Persistent Atrial Fibrillation (PersAF) – episodes lasting longer than seven days.
Volt CE Mark Study: Key Highlights at 12 Months
After a full year of patient follow-up, the Volt PFA System delivered outstanding results:
- Long-Term Effectiveness: The system maintained strong safety and efficacy profiles across both PAF and PersAF patient groups.
- Freedom from Arrhythmia: 83.5% of PAF patients and 58.1% of PersAF patients remained free from atrial arrhythmias — marking one of the lowest recurrence rates observed in long-term PFA studies.
- Quality of Life Improvement: Patients reported significant quality of life improvements, with scores increasing from 64.1 to 88.1 over 12 months.
- Exceptional Safety Record: Only 2.7% of patients experienced a primary safety event. There were no cases of hemolysis, coronary artery spasm, pulmonary vein stenosis, acute kidney injury, or phrenic nerve injury.
Moreover, the Volt PFA System achieved these results with fewer therapy applications — an average of just 4.7 applications per vein — compared to other PFA systems currently on the market.
Expert Insights on the Volt PFA System
According to the press release, Prof. Gian-Battista Chierchia praised the findings. He is the Director of the Atrial Fibrillation Program at the Heart Rhythm Management Institute at the University of Brussels.
“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 patient populations with unique needs. These data give us confidence in using the Volt PFA System in clinical practice.”
Procedural Flexibility Enhances Patient Care
Importantly, the Volt PFA System offers versatility in procedural settings. It supports a single-catheter approach, improves workflow, and enables flexibility for procedures under either light sedation or general anesthesia.
A new sub-analysis from the VOLT-AF IDE Study was presented at HRS 2025. It showed no significant differences in safety or acute effectiveness. This was consistent across procedures done under conscious sedation, deep sedation, or general anesthesia.
A Positive Impact on Patient Care
Reflecting on the broader impact, Dr. Christopher Piorkowski, Chief Medical Officer of Abbott’s Electrophysiology Business, remarked:
“Our goal with the Volt PFA System was to deliver outstanding outcomes for patients with a wide range of atrial arrhythmias. The latest data from the Volt CE Mark Study confirms that we are making a meaningful difference in patient care.”