Abbott has announced it received CE Mark in Europe for the Volt Pulsed Field Ablation (PFA) System, intended for treating atrial fibrillation (AFib). The device aims to improve workflows by allowing mapping, pacing, and ablating with a single catheter. According to Abbott, the system is designed to overcome limitations of existing PFA systems and enhance safety and effectiveness.
The approval was granted based on strong results from a global clinical trial conducted in Europe and Australia, which reported a 99.1% success rate in pulmonary vein isolation during ablation procedures. The company has started commercial cases within the EU, expanding use throughout the year.
Prof. Helmut Puererfellner in Austria, along with colleagues in Germany, Belgium, and the Netherlands, initially used the system. Prof. Puererfellner stated, "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 optimize PFA therapy."
The Volt PFA System aims to provide simplified workflow, efficient energy delivery, and procedural flexibility. It integrates with Abbott's EnSite X EP system to allow real-time contact visualization and accurate catheter positioning. Christopher Piorkowski, M.D., chief medical officer of Abbott's electrophysiology business, noted, "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."
Abbott's PFA portfolio, including the Volt PFA System, is undergoing further evaluation in the VOLT-AF Investigational Device Exemption Study. Nearly 400 patients are enrolled, and the study is set to complete the 12-month follow-up later this year.
The company has also progressed in evaluating focal PFA technology and has received regulatory approval for the Agilis NxT Steerable Introducer compatible with larger catheters used in PFA therapy.