Evaluación in vivo de un sistema robótico endovascular desechable para intervenciones vasculares periféricas...

Endovascular interventions expose operators to occupational radiation and ergonomic challenges that might be addressed by robotics. This in vivo study evaluated the safety and performance of a disposable robotic system for arterial peripheral vascular procedures.

This IRB-approved prospective, multicenter, single-arm study enrolled 20 patients requiring arterial peripheral vascular interventions across three U.S.

The primary endpoint was successful robotic navigation to predetermined targets without conversion to manual technique. Secondary endpoints included device-related adverse events, procedural efficiency, and operator radiation exposure.

The robotic system achieved 100% technical success (95% CI: 83.2-100%) in all 20 patients. No device-related serious adverse events or procedural complications occurred. Mean procedure time was 120.1 ± 34.5 minutes with a median of 117 minutes (range: 67.0-186.0). Robotic navigation time averaged 6.3 ± 7.6 minutes with a median of 3 minutes (1.0-32.0). Median fluoroscopy time was 7.9 minutes (1.0-18.10). Median operator radiation dose was 1.4 μSv (0.0-6.7μSv). All operators rated the system as intuitive and satisfactory (5.0/5.0 on all performance metrics).

This disposable endovascular robotic system exhibited technical success while achieving minimal operator radiation exposure and favorable user satisfaction scores, indicating its potential viability for broader implementation in arterial peripheral vascular interventional procedures.