ORION

Chronic total occlusions (CTOs) are severe vascular blockages that cause more than 100,000 deaths and around 6 million non-fatal complications worldwide each year. The ORION project is developing the first robotic system designed specifically for crossing CTOs, prepared for CE marking. In current treatment methods, rigid guidewires are pushed manually through calcified vessels, which often leads to perforations and failed procedures. ORION replaces this approach with a compact tableside robotic system that magnetically navigates the tip of a flexible microcatheter along an AI-generated 3D path. This path is created from previously acquired CT scans and merged in real time with live X-ray imaging to enable continuous visual guidance. Preclinical data suggest a potential 90 % reduction in perforations, a halving of procedure time to a maximum of 2.5 hours, and a reduction in X-ray exposure (fluoroscopy) from several hours to a maximum of four minutes, making the procedure considerably safer for clinicians and patients. The Dutch-German consortium will raise the system’s technology readiness level from TRL 5 to TRL 7 within 36 months, including validation in 20 large-scale preclinical CTO models and the creation of complete CE-compliant technical documentation (ISO 13485). The project will create around 5.5 sustainable high-tech full-time positions, strengthen three companies, and establish a lasting innovation ecosystem for robotic surgery in the cross-border region. The results will be disseminated through three public events, at least 30 digital outreach activities, and clear visibility for Interreg VI A.