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.
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Article info
Publication history
Published online: May 21, 2012
Accepted:
March 13,
2012
Received:
October 24,
2011
Footnotes
Financial Disclosure: A. Paz and K. Webster are paid consultants to Xenolith Medical Ltd; O. Zigman is an employee of Xenolith Medical Ltd; I. Tamir is a board member of Xenolith Medical Ltd; M. Monga is a study investigator funded by Xenolith Medical Ltd. and a paid consultant to Boston Scientific, Cook Urological, Bard Urological, and Gyrus ACMI. K. Webster is a former employee of Virginia Biosciences Commercialization Center.
Identification
Copyright
© 2012 Elsevier Inc. Published by Elsevier Inc. All rights reserved.
