A company specializing in electrophysiology solutions has announced that it has received the CE Mark approval for its 3D high resolution imaging and mapping system, and catheter, intended for imaging, diagnosing and treating complex arrhythmias.
The CE Mark (Conformité Européenne) will enable the company to begin commercial activities in Europe. This is the only system of its kind that can detect and display voltage-based, and high-resolution dipole-density charge-source maps. The system can also generate real-time 3D ultrasound images of heart chambers, that are comparable to those acquired by Magnetic Resonance Imaging (MRI), and Computed Tomography (CT) scanners.
The Acutus Medical (Carlsbad, CA, USA) AcQMap high-resolution imaging and mapping system, and the AcQMap Catheter, can be used to map and display stable, and unstable cardiac arrhythmias. By mapping complex arrhythmias in real-time, and finding cardiac activation mechanisms, the system can provide an accurate guide for ablation therapy. The system is not currently sold in the US.
Andrew Grace, MD, PhD, Papworth Hospital (Cambridgeshire, UK), said, “During a recent AcQMap procedure, we were able to systematically map Atrial Fibrillation (AF) and eliminate the identified sites of interest, ultimately restoring the patient to their native rhythm. The ability to map and quickly re-map after each set of ablations makes it possible to truly visualize AF and to achieve sinus rhythm.”