Volta Medical’s AF-Xplorer obtains a CE Mark as per European Medical Device Regulation MDR 2017/745

Volta Medical, a leading health tech company, has obtained CE Mark for its Volta AF-Xplorer under the new European Medical Device Regulation MDR 2017/745. This AI tool aids electrophysiologists in annotating spatiotemporal dispersions during AF and atrial tachycardia (AT) procedures. With FDA clearance in the US, the AF-Xplorer is set to enhance sales in the European Union as an upgrade to Volta’s VX1 device. Utilizing machine learning algorithms trained on expert-annotated electrograms, it standardizes the identification of AF sources. TAILORED-AF, a multicenter trial, compares conventional to Volta-guided ablation in persistent AF cases. Volta also initiates RESTART, a trial assessing its AI solution in recurrent AF patients. TAILORED-AF aims to establish the superiority of Volta's AI-guided ablation strategy over conventional methods. Primary endpoints include AF episode absence post-ablation, with secondary safety measures. Results are anticipated in 2024.