Initial Multicenter Evaluation of a Novel Anchoring Exchange Device: AI-based Quantitative Distal Tip-Motion Analysis

Area of Science:

• Neurosurgery
• Interventional Radiology
• Medical Device Technology

Background:

• Intracranial angioplasty and stent deployment carry risks of unintended distal tip motion, potentially causing vessel injury.
• Conventional guidewire exchange maneuvers are a known source of this complication.

Purpose of the Study:

• To evaluate a novel anchoring exchange device, the Medilizer, designed to stabilize the distal tip during intracranial angioplasty.
• To compare the efficacy of the Medilizer against conventional wires in reducing distal tip motion.

Main Methods:

• A comparative study involving angioplasty of intracranial stenosis across three institutions.
• Exchange maneuvers were performed using conventional wires and the Medilizer device.
• AI-assisted tracking of biplane fluoroscopic sequences quantified distal tip motion trajectory length.

Main Results:

• Analysis included 20 conventional wire views and 13 Medilizer views.
• The Medilizer demonstrated a significant reduction in distal tip motion trajectory length (3.3 mm vs. 35.9 mm, p < 0.001), representing approximately a 90% improvement.
• No adverse events were reported in any of the procedures.

Conclusions:

• The anchoring exchange device (Medilizer) shows significant clinical advantages in stabilizing the distal tip during intracranial angioplasty.
• AI-assisted quantitative analysis provides an objective measure for evaluating endovascular device performance.
• Further validation studies are warranted to confirm these findings.