First-in-man (FIM) experience with the Magnetic Medical Positioning System (MPS) for intracoronary navigation

Abstract

To investigate the safety and feasibility of a newly developed magnetic navigation system for intracoronary tracking. The MediGuide Medical Positioning System (MPS) is a navigation system that was developed to facilitate the navigation of enabled devices within the coronary tree using a magnetic tracking technology. The current prospective, non-randomised, single-centre, first-in-man study was conducted at Universitätsklinikum Regensburg (UKR), Germany on an MPS-enabled AXIOM Artis dFC coronary angiography system (Siemens AG, Forchheim, Germany). We enrolled 20 patients who required IVUS assessment or treatment of a single de novo target lesion in a native coronary artery. The performance was evaluated on a semi-quantitative one-to-five scale where a score of five indicates an excellent superimposition with the vessel and a score of one an unacceptable performance. The mean score for tracking as assessed by projection on life fluoroscopy was 4.89 and 3.58 as assessed by projection on recorded cine-loop. Length measurement of a 20 mm distance was significantly better with the MPS (mean deviation of 0.6 mm=3%) as compared to standard QCA (1.5 mm=8%, p<0.05). Creating a 3D reconstruction was possible in 13 out of 20 cases with an average score of 4.68. No adverse events occurred. The MediGuide Medical Positioning System is safe and feasible in man, facilitates intracoronary navigation and allows 3D reconstruction of the investigated coronary segment.