US-based medical device firm Abbott has unveiled new data from its Volt CE Mark Study, showing the long-term safety and efficacy of its Volt PFA System for treating atrial fibrillation (AFib).
The Volt PFA System is designed to use high-energy electrical pulses to target cardiac tissue, providing a strong safety profile and effectiveness.
The CE mark study showed sustained benefits of pulsed field ablation (PFA) therapy over a period of 12 months.
It enrolled 150 patients across 11 European sites to treat symptomatic, recurrent, drug-refractory paroxysmal atrial fibrillation (PAF) and persistent AFib (PersAF).
In the study, the PFA System’s performance surpassed that of the available PFA systems.
Additional imaging assessments in a feasibility sub-study confirmed the safety of the system.
Abbott electrophysiology business chief medical officer Christopher Piorkowski said: “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.
“The latest data from the Volt CE Mark Study is confirmation that the system will truly impact patient care in a positive way.”
After 12 months, 83.5% of PAF patients and 58.1% of PersAF patients remained free from atrial arrhythmia, achieving one of the lowest recurrence rates in long-term PFA studies.
Patients also reported significant quality of life improvements, with scores increasing from 64.1 to 88.1.
The Volt PFA System’s safety profile was further validated, with only 2.7% of patients experiencing a primary safety endpoint event.
The study showed no instances of haemolysis, coronary artery spasm, pulmonary vein stenosis, acute kidney injury, or phrenic nerve injury.
The system’s single-catheter approach enhances procedural workflow and flexibility, accommodating either light sedation or general anaesthesia.
A sub-analysis from the VOLT-AF IDE Study showed no significant differences in safety or effectiveness between procedures, regardless of anaesthesia.
Following CE Mark certification, the Volt PFA System has been confirmed to effectively treat both PAF and PersAF patients, expanding its potential impact on AFib treatment.
University of Brussels Heart Rhythm Management Institute atrial fibrillation program director Gian-Battista Chierchia said: “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.
“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.”
