Wingspan Stent System - Prosthesis, internal, stent, vascular

Intended purpose

The Wingspan® Stent System, when used together with the Gateway® PTA Balloon Catheter, is indicated for use in improving cerebral artery lumen diameter in patients 22 to 80 years old with recurrent (2 or more) strokes refractory to a comprehensive regimen of medical therapy and due to atherosclerotic disease of intracranial vessels with 70-99% stenosis that are accessible to the system. The most recent stroke must have occurred more than 7 days prior to treatment with the Wingspan Stent System. Patients are eligible for treatment with the Wingspan Stent System if their Modified Rankin Score (mRS) is 3 or less at the time of treatment

Functional description

The Wingspan Stent System includes a self-expanding nitinol stent with four radiopaque marker bands on each end (distal and proximal) and a flexible over-the-wire stent delivery catheter with pre-loaded stent.