Wingspan® Stent System with Gateway® PTA Balloon Catheter

Title: “Wingspan Stent System with Gateway PTA Balloon Catheter”

Study Sponsor: Stryker

Principal Investigator: Matthew Lawson, MD

Study Synopsis: Humanitarian Use Device: For use in improving cerebral artery lumen diameter in patients with intracranial atherosclerotic disease, refractory to medical therapy in intracranial vessels with≥ 50% stenosis that are accessible to the system.

The Wingspan Stent System with Gateway PTA Balloon Catheter is a new device that has been approved by the Food and Drug Administration (FDA) as a Humanitarian Use Device (HUD) for use as an alternative treatment. A HUD device used to diagnose or treat a disease or condition affecting fewer than 4,000 individuals in the United States per year. The probable benefit to health outweighs the risks of injury or illness.

Study Status: Only for patients with intracranial atherosclerotic disease with more than 50% stenosis.

For more information, contact Lutheria Hollis, CCRC, at (850) 877-5115.

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