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

Volta Medical has obtained the CE Mark for its Volta AF-Xplorer under the new European Medical Device Regulation MDR 2017/745, allowing sales in the European Union. This AI companion assists in annotating spatiotemporal dispersions during atrial fibrillation (AF) and atrial tachycardia (AT) procedures. Using machine and deep learning algorithms trained on expert-annotated electrograms (EGMs), it identifies AF sources. The AF-Xplorer, an advanced version of Volta’s VX1 device, also received FDA clearance for these procedures in January 2023.

Volta is enrolling patients in the RESTART trial, assessing its AI solution for recurrent AF patients who had unsuccessful ablations. Meanwhile, the TAILORED-AF trial aims to determine if a tailored VX1 AI-guided ablation combined with pulmonary vein isolation is superior to conventional ablation for persistent AF. Expected results are in 2024.