Aims: To investigate the safety and feasibility of a newly developed magnetic navigation system for intracoronary tracking.
Methods and results: 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.
Conclusions: The MediGuide Medical Positioning System is safe and feasible in man, facilitates intracoronary navigation and allows 3D reconstruction of the investigated coronary segment.