Safety and Efficacy of a Novel Ureteral Occlusion Device

Objective To evaluate the safety of a novel ureteral occlusion device and compare its performance with that of other devices and guidewires. Methods The XenX (Xenolith Medical) was tested in an ex vivo porcine model to determine the percentage of denuded urothelium because of manipulation within the ureter, the capacity to prevent stone migration during laser lithotripsy, stent compatibility, and the ability to be used for stent placement. Comparative evaluations of the insertion forces and maneuverability were conducted in an in vitro ureter model with the XenX, Stone Cone (Boston Scientific), NTrap (Cook Urological), HiWire (Cook Urological), Roadrunner (Cook Urological), and Sensor (Boston Scientific). Stone migration efficacy was measured using a controlled distribution of stones in 4- and 10-mm silicone tubing with the XenX, NTrap, and Stone Cone. Results The XenX was safely manipulated within the ureter, prevented significant particle migration during laser lithotripsy, and effectively placed stents. The NTrap required the greatest force when attempting to navigate past a stone ( P = .0003), followed by the Stone Cone ( P = .009), with little difference among the other devices ( P > .72). No differences were found for the passing forces ( P = .061), interval to pass ( P = .30), or number of attempts to pass the stone ( P = .68). The XenX prevented stone migration the most, with more notable differences in the 10- than in the 4-mm tubing. Conclusion Ex vivo evaluations hold promise for the XenX to be safely and effectively used during ureteroscopic procedures. Clinical evaluations are warranted to confirm the safety and performance of the XenX relative to the other ureteral occlusion devices.