Humanitarian Use Device: Wingspan Stent System with Gateway PTA Balloon Catheter
Aims: This device is used to increase cerebral artery blood flow in patients with intracranial atherosclerotic disease. A stent is placed in the affected area and is deployed by inflation of a very small balloon, which widens the occluded vessel.
Principal Investigator: Shakeel Chowdhry, MD
NorthShore Project Number: EH12-355
Sponsor: N/A - Manufacturer: Boston Scientific
Contact: Please call 847.570.4224 with questions regarding the device.
Open to Enrollment: Yes - patients are being treated with this device.
Humanitarian Use Device: The PulseRider Aneurysm Neck Reconstruction Device® (ANRD)
Aims: This device acts as a support for the treatment of un-ruptured, wide-necked bifurcation aneurysms in the brain. A bifurcation aneurysm is a specific type of aneurysm that arises at the point at which there is a division of one major vessel into two branches.
Principal Investigator: Shakeel Chowdhry, MD
NorthShore Project Number: EH17-313
Contact: Call 847.570.4224 with questions regarding this device.
Open to Enrollment: Yes – patients are being treated with this device.
Note: Humanitarian Use Devices
A Humanitarian Use Device (HUD) is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year. A device manufacturer`s research and development costs could exceed its market returns for diseases or conditions affecting small patient populations. The HUD provision of the regulation provides an incentive for the development of devices for use in the treatment or diagnosis of diseases affecting these populations. An approved HDE authorizes marketing of the HUD. However, an HUD may only be used in facilities that have established a local institutional review board (IRB) to supervise clinical testing of devices and after an IRB has approved the use of the device to treat or diagnose the specific disease. The labeling for an HUD must state that the device is an humanitarian use device and that, although the device is authorized by Federal Law, the effectiveness of the device for the specific indication has not been demonstrated.