Stent System for Brain Arteries

The U.S. Food and Drug Administration (FDA) has granted a humanitarian-device exemption (HDE) approval of the system for the treatment of atherosclerotic disease and its use is indicated for improving cerebral artery lumen diameter in patients who have been unresponsive to medical therapy.

The approval was based on a safety study conducted at 12 sites in Europe. The study enrolled patients who had a stroke caused by an intracranial lesion and for whom medical treatment failed to prevent another stroke. The stent had a procedural success rate of 97.7% and showed only a 4.4% incidence of death or stroke in the same hemisphere of the brain within 30 days.

The Wingspan system with Gateway percutaneous transluminal angioplasty (PTA) balloon catheter is the product of Boston Scientific (Natick, MA, USA).

"Intracranial atherosclerotic disease is a serious condition and current medical management still leaves many patients at risk for another stroke,” noted John Barr, M.D., president of the American Society of Interventional Therapeutic Neuroradiology (ASITN), speaking at the ASITN annual meeting in Oahu (Hawaii) in August 2005.
"This study suggests that the Wingspan device can open arteries safely and offers new hope for the prevention of ischemic stroke.”




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