US-based medical device company Abbott has received CE mark approval for its Volt pulsed field ablation (PFA) System, which treats patients with atrial fibrillation (AFib).
Building on Abbott’s electrophysiology (EP) portfolio, the Volt PFA System integrates mapping, pacing, and ablation into a single catheter, enhancing treatment efficacy for AFib.
The system delivers high-energy electrical pulses to targeted cardiac tissue areas, reducing the risk of damaging adjacent tissue in patients with complex conditions.
It stands out from traditional systems by integrating with Abbott’s EnSite X EP system to address limitations such as poor visualisation and contact assessment.
The Volt PFA System provides a simplified workflow through its single-catheter approach.
It offers a real-time contact visualisation to assist physicians in accurately positioning the catheter for therapy delivery.
The system features a unique balloon-in-basket design that enables effective energy transfer directly to targeted tissue, minimising the number of therapy applications required.
Also, it allows patients to undergo ablation procedures under light sedation or general anaesthesia, based on physician and hospital preference, enhancing procedural flexibility.
The CE mark approval allows Abbott to start commercialising the system in the Volt PFA System, a part of its electrophysiology portfolio, in the European Union (EU).
Abbott electrophysiology business chief medical officer Christopher Piorkowski said: “While PFA is a relatively new therapy option, we’ve incorporated lessons learned from first-generation devices and designed the Volt system to simplify PFA procedures while making them more efficient.
“Clinical data has also shown that the Volt catheter’s cutting-edge design helps physicians achieve pulmonary vein isolation in fewer ablation attempts and less therapy applications for improved patient outcomes.”
The CE mark approval was based on robust outcomes from Abbott’s Volt CE Mark study, a global clinical trial conducted at centres in Australia and Europe.
In the study, Volt achieved pulmonary vein isolation (PVI) in 99.1% of veins during ablation procedures, with significantly fewer energy applications than existing PFA systems.
The regulatory approval was granted earlier than anticipated, allowing Abbott to initiate commercial cases with physicians who participated in Abbott’s PFA clinical studies.
Initial procedures have been performed by several physicians, including Helmut Puererfellner at Ordensklinikum hospital in Austria.
Furthermore, the medical device company plans to expand the use of the Volt PFA System in EU markets throughout the second half of this year.
Puererfellner said: “The launch of Abbott’s Volt PFA system marks a major milestone in the evolution of electrophysiology across Europe and signals we’re moving beyond early therapy approaches to new systems that incorporate key physician feedback and clinical insights to optimise PFA therapy.
“PFA is significantly changing our approach to treating patients and it’s exciting to see the Volt PFA System build on the therapy’s potential and bring new benefits to clinical teams so we can improve the lives of more patients battling conditions like AFib.”
