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Wingspan Stent System PTA Balloon Catheter (Humanitarian Use Device)

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The Wingspan Stent System with the Gateway TM PTA balloon catheter is intended for use in improving cerebral artery lumen diameter in patients with intracranial atherosclerotic disease refractory to medical therapy, in intracranial arteries with greater than or equal to 50% stenosis. The product was granted a Humanitarian Use Device (HUD, a designation for devices that will be used to treat fewer than 4000 people a year) in January 2004 because there are no equivalent devices available for the treatment of intracranial atherosclerotic disease.

Over 700,000 Americans suffer from a stroke each year. Of these strokes, 468,000 are caused by ischemic disease due to an arterial blockage. Approximately 10% of ischemic strokes are due to intracranial arterial stenosis (narrowing). Intracranial stenosis has been traditionally treated by medical therapy only, but this entails a high risk of recurrence if the stenosis is greater than 50%. Angioplasty and stenting is an alternative treatment that has proven effective in treating other arteries in the body, and is now made available for arteries in the brain.

Contact Dr. Gobin: 212-746-4998