Neurological Devices Panel of the Medical Devices Advisory Committee

Neurological Devices Panel of the Medical Devices Advisory Committee
Committee meeting on March 23, 2012 from 8:00 a.m. to 7:00 p.m.

Agenda: On March 23, 2012, the committee will discuss current knowledge about the safety and effectiveness of the Wingspan Stent System with Gateway PTA Balloon Catheter for the treatment of intracranial arterial stenosis. FDA is convening this committee to seek expert scientific and clinical opinion on the risks and benefits of this device based on the available premarket and postmarket data. The Wingspan Stent System with Gateway PTA Balloon Catheter is a neurovascular stent, balloon catheter, and delivery system consisting of the following components:

Wingspan Stent--This is a self-expanding, nitinol stent with a tubular mesh design.
Gateway PTA Balloon Catheter--This balloon catheter is used to predilate the lesion prior to introduction of the Wingspan Stent System into the patient.
Wingspan Delivery System--This delivery system is a single lumen, over-the-wire, coaxial microcatheter that is used to deliver the stent to the treatment site within the patient’s artery.

The Wingspan Stent System with Gateway PTA Balloon Catheter has been approved under a humanitarian device exemption (HDE) (H050001) for the following indications: "The Wingspan Stent System with Gateway PTA Balloon Catheter is indicated 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.