Safety and feasibility study of a novel robotic system in an in vivo porcine vascular model.

PURPOSE: The goal of this preclinical study is to assess the functionality, technical feasibility, and safety of a new vascular robotic LIBERTYR 3 System, in the microcatheterization of vascular targets using a range of guidewires and microcatheters.

MATERIAL AND

METHODS

An anesthetized pig served as an arterial model for the robotic device (LIBERTYR3; Microbot Medical Ltd, Yoqneam, IL). The primary efficacy endpoint was the evaluation of its capability to selectively catheterize predetermined distal arterial branches in the liver, kidneys, and mesenteric arteries (technical success), under fluoroscopy guidance. The primary safety endpoint was the occurrence of angiographic acute catheterization-related complications (dissection, thrombosis, embolism, perforation). The catheterizations were conducted by two interventional radiologists that present different work experience in endovascular procedures (18 and 2 years respectively), using a variety of microcatheters and wires. Various procedural parameters such as functionality, practicality, ease of use, and time required for selective catheterization, were evaluated, and recorded.

RESULTS

All pre-determined arteries were successfully selectively catheterized (100% technical success), by both operators. No angiographic acute complications occurred. The microcatheters and wires were manipulated using the remote portable console in an effortless manner that maintained a high level of accuracy. Mean time for selective catheterization was 131 ± 82 s. The robot's conversion function to manual operation was successfully demonstrated.

CONCLUSION

Robotic navigation and catheterization of selected target arteries were accomplished without observable vascular damage, suggesting that the LIBERTYR 3 robotic system is a reliable and safe tool for robotic-assisted endovascular navigation. Further experimental studies are required to evaluate safety and efficacy prior to introduction into clinical practice.