Reconstructive Device for AneurysmsPosted on June 14, 2007
In some cases, Dr. Lopes also uses the CORDIS ENTERPRISE Vascular Reconstructive Device (VRD) and Delivery System (DS) to treat wide-neck aneurysms. Like the Neuroform Stent, the Enterprise Vascular Reconstructive Device meets all of the criteria of a Humanitarian Use Device, and the United States Food and Drug Administration has authorized its use as a Humanitarian Use Device for treatment of wide-necked, intracranial, saccular or fusiform aneurysms
A Humanitarian Use Device is a device used to diagnose or treat a disease or condition that affects fewer than 4,000 individuals in the United States per year and for which no comparable device is available. The FDA encourages treatment for rare conditions, so it permits the use of a device it designates as a Humanitarian Use Device. Its permission is 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. The FDA does not require as thorough or as extensive of testing in order to demonstrate the safety and effectiveness of a Humanitarian Use Device as compared to the requirements of devices intended to treat more common conditions.
The CORDIS ENTERPRISE VRD and DS can be placed in a brain artery, or vessel in the brain, and across the neck, or opening, of an aneurysm. After Dr. Lopes positions the Cordis Enterprise VRD, the aneurysm sac can be filled with small metal coils. The Enterprise VRD keeps the coils within the aneurismal sac and in turn, the coils prevent blood from flowing into the aneurysm. Dr. Lopes believes this coiling-assisted procedure could greatly reduce the risk of aneurysm rupture. The use of the device does not involve research or data collection.
Participation criteria include:
- Patient has wide-neck, intracranial, saccular or fusiform aneurysms
- Parent vessel has a diameter of greater than or equal to 3mm and less than or equal to 4mm.
- Wide-neck is defined as having a neck width greater than or equal to 4 mm or a dome-to-neck ratio of less than 2 mm.
Enrollment at Rush University Medical Center is ongoing. For additional information, call Dr. Lopes at 312-563-4000 or email info@ChicagoStrokeMD.com