A novel intracranial exchange guidewire improves the navigation of various endovascular devices: An in vitro study of challenging situations

Abstract

Objective Neuroendovascular procedures rely on successful navigation and stable access to the target vessel. The Stabilizer is a 300 cm long exchange wire with a 0.014 diameter and a soft, flexible stent at the distal end designed to assist with navigation and device delivery. This study aims to assess the efficacy of the Stabilizer for navigation in a variety of challenging environments. Methods The efficacy of the Stabilizer was evaluated using three challenging vascular models: a giant aneurysm model, a severe tortuosity model, and an M1 stenosis model. The Stabilizer was compared with a conventional wire during navigation in each model. Results In the giant aneurysm model, there was no significant difference of success during straightening of a looped wire and significantly higher success rates when advancing an intermediate catheter with the Stabilizer beyond the aneurysm neck compared to a conventional guidewire. The Stabilizer also significantly increased success rates when advancing an intermediate catheter through a model with severe tortuosity compared to a conventional guidewire, as well as exchange maneuver for intracranial stenting in a stenosis model compared to an exchange wire. Conclusions In our experimental model, the Stabilizer significantly improved navigation and device delivery in a variety of challenging settings compared to conventional wires.

First-in-human trial of Stabilizer device in neuroendovascular therapy

“…A balloon can be used in a similar fashion to the Stabilizer to prevent accidental movement of the guidewire. However, the Stabilizer has the added advantage of allowing blood flow through the vessel during the exchange [ [8] , [9] , [10] , [11] ]. Traditional stent retrievers have also been used for difficult navigation or exchange maneuvers but because the push wire is not long enough, special precautions are necessary to prevent air embolism [ 9 ].…”

“…A recent in vitro study demonstrated significantly greater success with the Stabilizer when navigating challenging settings and performing exchange maneuvers with stiff devices compared to a traditional guidewire [ 11 ]. In this first-in-human experience using the Stabilizer, we were able to successfully navigate the device in all five cases with no clinically significant adverse events.…”