Jefferson neurosurgeons using new liquid treatment for wide-neck brai...(e-neck aneurysms have such a large openi...),Health

Researchers noted they are not recruiting patients, as this is not a clinical study.

Rather, this is a Humanitarian Use Device which is 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 Food and Drug Administration (FDA) allows physicians to use such a device under a Humanitarian Device Exemption, when a device maker chooses not to do formal research studies to test a product as it would be used to treat a smaller population of patients.

Before the FDA gave the exemption, it looked at facts given by the maker of the device and decided that the likely risks of using the system are within reason, compared to the possible benefits of using this device and compared to other treatments for a wide neck aneurysm, said Dr. August. Research studies have not been done to show whether this system works for treating wide-neck aneurysms.

By filling the aneurysm sac or pocket with the liquid, blood flow into the aneurysm is blocked, helping to prevent the aneurysm from rupturing or increasing in size.

This treatment is done endovascularly and essentially consists of inserting a catheter into the blood vessel to cut off the blood supply. The material is delivered by slow-controlled injection through a very micro-size catheter into the aneurysm under x-ray visualization. The catheter is initially inserted into a vessel in the groin area and threaded to the vessel where the aneurysm is located. The material enters the aneurysm as a liquid through the catheter and then begins to solidify from the outside to the inside with final solidification or embolization occurring within five minut
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