In Vivo Evaluation of a Disposable Endovascular Robotic System for Arterial Peripheral Vascular Interventions: A Multicenter Feasibility Study.

PURPOSE: To evaluate the safety and performance of a disposable robotic system for arterial peripheral vascular procedures.

MATERIALS AND

METHODS

This institutional review board (IRB)-approved prospective, multicenter, single-arm study enrolled 20 patients requiring arterial peripheral vascular interventions across 3 U.S.

CENTERS: 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.

RESULTS

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 minutes (SD ± 34.5) with a median of 117 minutes (range, 67.0-186.0 minutes). Mean robotic navigation time was 6.3 minutes (SD ± 7.6) with a median of 3 minutes (range, 1.0-32.0 minutes). Median fluoroscopy time was 7.9 minutes (range, 1.0-18.10 minutes). Median operator radiation dose was 1.4 μSv (range, 0.0-6.7 μSv). All operators rated the system as intuitive and satisfactory (5.0 out of 5.0 on all performance metrics).

CONCLUSIONS

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.