Humanitarian Use Device: Neuroform Microdelivery Stent System
Aims: The Neuroform Microdelivery Stent System is used with coils for treating wide neck aneurysms in the brain that cannot be treated with open brain surgery.
Principal Investigator: Hamad Farhat, MD
IRB Approval Number: EH12-352
Funding Source: N/A - Manufacturer: Boston Scientific
Contact: Please call Robert Frech at 847.570.4224 with questions regarding the device.
Open to Enrollment: Yes - patients are being treated with this device.
Note: Humanitarian Use Devices

Humanitarian Use Device: Onyx Liquid Embolic System for Treatment of Intracranial Aneurysms (Onyx HD-500)
Aims: The Onyx HD-500 material is placed within an aneurysm to occlude or block blood flow into the large and giant, wide-necked aneurysms. The material may offer a benefit in particular cases that other devices may not.
Principal Investigator: Hamad Farhat, MD
IRB Approval Number: EH12-353
Funding Source: N/A - Manufacturer: ev3 Neurovascular
Contact: Please call Robert Frech at 847.570.4224 with questions regarding the device.
Open to Enrollment: Yes - patients are being treated with this device.
Note: Humanitarian Use Devices

Humanitarian Use Device: Codman ENTERPRISE Vascular Reconstructive Device and Delivery System
Aims: This device is used for treatment of wide neck aneurysm; a stent is placed across the opening or neck of the aneurysm to secure the placement of coils and to maintain blood flow through the artery in which the stent is placed
Principal Investigator: Hamad Farhat, MD
IRB Approval Number: EH12-354
Funding Source: N/A – Manufacturer: Codman Neurovascular
Contact: Please call Robert Frech at 847.570.4224 with questions regarding the device.
Open to Enrollment: Yes - patients are being treated with this device.

 

 


Note: Humanitarian Use Devices

 

An 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.

 

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