Wide-Neck AneurysmsPosted on June 30, 2008
The Neuroform Microdelivery Stent, is a Humanitarian Use Device, which Dr. Lopes frequently uses in the treatment of wide neck, intracranial aneurysms. In fact, Dr. Lopes is one of the most experienced practitioners in the world using this specialized stent to treat wide-neck aneurysms using the minimally-invasive endovascular approach. Prior to the introduction of the Neuroform Stent, patients with wide-neck aneurysms had no other choice than to undergo open surgery.
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 United States Food and Drug Administration encourages treatment for rare conditions, so it does not require as thorough or extensive testing to demonstrate safety and effectiveness as 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.
The Neuroform Microdelivery Stent, for treatment of wide-necked intracranial aneurysms, meets all of the criteria of a Humanitarian Use Device and the FDA has authorized its use as a Humanitarian Use Device. In other words, the Neuroform Microdelivery Stent, when used to treat a wide-necked, intracranial aneurysm, does not require FDA approval. It only requires that it meet the criteria the FDA has put in place for a Humanitarian Use Device. The use of the device does not involve research or data collection.
The Neuroform Microdelivery Stent can be placed in a brain artery, or a blood vessel in the brain, across the opening of an aneurysm. After the stent is in place, the aneurysm sac can be filled with small metal coils. The coils prevent blood from flowing into the aneurysm and could greatly reduce the risk of aneurysm rupture. The Neuroform Microdelivery Stent is a small metallic mesh tube that is designed to keep the coils in the aneurysm sac.
Eligibility requirements for the Neuroform Stent include:
- Parent vessel with diameter greater than or equal to 2mm but less than or equal to 4.5 mm
- Aneurysm not amenable to treatment with surgical clipping
- Aneurysms with a wide neck:
- Neck greater than or equal to 4 mm, OR
- Dome-to-neck radio of less than 2 mm
Enrollment is ongoing. For additional information, contact Dr. Lopes at Rush University Medical Center at 312/563-400 or at info@ChicagoStrokeMD.com.