Neurological surgeons at Jefferson Hospital for Neuroscience are among the first surgeons in the United States using an FDA-approved liquid system for treating wide-necked brain aneurysms, which could eventually replace current treatments.
Principal investigator Erol Veznedaroglu, M.D., associate professor of Neurological Surgery and director of the division of Neurovascular Surgery and Endovascular Neurosurgery, Thomas Jefferson University Hospital, is one of the few surgeons selected to explore the use of a liquid embolic (blocking) system to fill wide-neck brain aneurysms, which have a wide opening where the aneurysm arises from the artery or blood vessel. A brain aneurysm is a weakness in a major blood vessel that causes a portion of the vessel wall to balloon out. This abnormality puts an individual at risk should the aneurysm break open and bleed.
“A wide-neck brain aneurysm is relatively uncommon and occurs in about 25 percent of persons with brain aneurysms,” said Dr. Veznedaroglu. “Wide-neck aneurysms can be difficult to treat both surgically (brain surgery to clip off the aneurysm) and endovascularly (treatment done from within the blood vessel), which are methods used to treat other types of brain aneurysms.”
“The potential benefit of the liquid embolic system may be the complete or partial blockage of the blood supply to the aneurysm,” said Deborah L. August, M.D., MPH, director of Clinical Research in the department of Neurological Surgery, Jefferson. “It may also help to correct or lessen some symptoms.”
Current treatments for brain aneurysms include open brain surgery to clip the aneurysm and coil embolization or coiling, less–invasive surgical procedure. For coiling, a catheter is inserted into an artery in the groin, then advanced into the affected artery in the brain. X-rays are used to guide the catheter into the artery.
“Coils are the most commonly used embolization device but some wide-neck aneurysms have such a large opening that the coils may not stay inside the aneurysm sac,” said Dr. Veznedaroglu. “In this case, the coils can fall back into the blood vessel and block or partly block the blood flow.”
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.