Preventing Stroke from Brain Artery DiseasePosted on August 3, 2005
Wingspan Stent System
It is estimated that ten percent of ischemic strokes are caused by narrowing of the blood vessels in the brain, also referred to as intracranial atherosclerosis. The Wingspan Stent System with Gateway PTA Balloon Catheter is a Humanitarian Use Device that may be of use in treating intracranial atherosclerotic disease. The use of the device does not involve research or data collection. The Wingspan Stent System with Gateway PTA Balloon Catheter consists of a Wingspan Stent, a Wingspan Delivery System, and a Gateway PTA Balloon Catheter.
A Humanitarian Use Device is a device used to diagnose or treat a disease or condition that affects very few individuals in the United States per year and for which no comparable device is available. The United States Food and Drug Administration (FDA) encourages treatment for rare conditions, so the FDA does not require as thorough testing to demonstrate the safety and effectiveness of Humanitarian Use Devices as it does for devices intended to treat more common conditions. The FDA permits the use of Humanitarian Use Devices based primarily on evidence that the device does not pose a significant risk of injury to the patient and that the potential benefit of the device to the health of the patient outweighs the risks of its use. In other words, the Wingspan Stent System with Gateway PTA Balloon Catheter does not require FDA approval when used to treat intracranial atherosclerotic disease. The Wingspan Stent System with Gateway PTA Balloon Catheter, for treatment of intracranial atherosclerotic disease, meets all of the criteria of a Humanitarian Use Device and the FDA has authorized its use as a Humanitarian Use Device.
Eligibility requirements include:
- patients with intracranial atherosclerotic disease,
- refractory to medical therapy,
- intracranial vessels with greater than or equal to 50% stenosis