Abbott has reported new data from its prospective, non-randomised Volt CE Mark Study, indicating that individuals treated with pulsed field ablation (PFA) therapy using the Volt PFA System for atrial fibrillation (AFib) showed efficacy and safety up to 12 months.
This study was designed to evaluate the system’s impact on two distinct subject groups: those with paroxysmal atrial fibrillation (PAF), in which episodes come and go, and those with persistent AFib (PersAF), where episodes last longer than seven days.
A total of 150 subjects were enrolled in this single-arm, multicentre study across 11 European sites, and it also included a feasibility sub-study with additional imaging evaluations to confirm the system’s acute safety.
According to the study data, after one year, the system achieved results, with 83.5% of PAF subjects and 58.1% of PersAF subjects remaining atrial arrhythmia-free.
Additionally, the quality of life (QoL) assessment scores improved from 64.1 to 88.1 over the same period.
The safety profile of the system was also found to be notable, with 2.7% of subjects experiencing a primary safety endpoint event, and no cases of haemolysis, acute kidney injury, pulmonary vein stenosis, coronary artery spasm, or phrenic nerve injury reported.
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By GlobalDataThe system offers a single-catheter PFA approach, enhances workflow and procedural flexibility, enabling either light sedation or general anaesthesia.
A sub-analysis from the study found no significant difference in safety or acute effectiveness results between procedures performed under conscious or deep sedation and those with general anaesthesia.
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, and the latest data from the Volt CE Mark Study is confirmation that the system will truly impact patient care in a positive way.”
Earlier this month, the company launched a next-generation delivery system to simplify the electrode implantation process for its Proclaim DRG neurostimulation system.
