ArticleNeuroradiology2026
First-in-human use of SmartGUIDE
Article in Neuroradiology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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12 authors.
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Abstract
purposeTo report the first-in-human, prospective clinical evaluation of a steerable 0.014″ microguidewire SmartGUIDE™ (Artiria Medical, Switzerland) for endovascular treatment of intracranial aneurysms, assessing technical feasibility, safety, and operator-reported usability.
methodsAdult patients undergoing elective treatment of unruptured intracranial aneurysms were prospectively enrolled between August 2023 and July 2024 at a single center. All procedures were performed by a senior neurointerventionalist. The primary endpoint was the device technical success, defined as successful SmartGUIDE™ navigation to a predefined anatomical target. Successful microcatheterization over the wire was a clinically meaningful secondary endpoint, together with safety, device-related adverse events, navigation time, and operator-reported usability (5-point Likert scale). Patient-specific Flow Twin
resultsFive patients were included. SmartGUIDE™ successfully reached the predefined target in all procedures (5/5). Microcatheterization was achieved in four cases (4/5). Median SmartGUIDE navigation time was 7 min (IQR 4-10). No wire-related complications or device malfunctions were observed. Operators reported high device usability, with median Likert scores of 4-5/5 across all parameters. At 1-year follow-up, all aneurysms demonstrated complete and stable occlusion without neurological morbidity.
conclusionThis first-in-human prospective series supports the feasibility and safety of the SmartGUIDE™ steerable 0.014″ microguidewire for the treatment of intracranial aneurysms. The study reports reliable navigation to the target without device-related malfunction or complication, favorable operator-reported usability, and highlights the value of incorporating patient-specific flow-models for pre-procedural training. Comparative studies are required to establish efficiency advantage over conventional microguidewires.
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