The FDA approved a new glue for use in a rare form of brain surgery
performed when the blood vessels in the brain are intertwined, putting
patients at risk of stroke and death.
The glue, made by Cordis Neurovascular Inc., of Miami Lakes, Fla.,
was approved for use in patients at risk of hemorrhaging and dying from
cerebral arteriovenous malformations (AVMs) to reduce blood loss by
blocking blood vessels in the brain before surgery.
The glue is infused into the blood vessels via a catheter inserted
into the leg and threaded up to the brain. Later, the glue is removed
during surgery to remove the AVM.
Approval of the product, Trufill n-BCA Liquid Embolic System, was based on
a review of pre-clinical and clinical studies of safety and effectiveness conducted
by Cordis and on the recommendation of the Neurological Devices Panel of FDA's
Medical Devices Advisory Committee.
The firm's multi-center study of 104 patients showed that the glue
was as effective in blocking blood flow as standard treatment with poly-
vinyl alcohol. In the study, half the patients were treated with the
glue; half with poly-vinyl alcohol. Both groups had about the same rate of
Approximately 4,000 cerebral AVM procedures are performed each
year in the United States.