FRIDAY, April 08, 2005 (HealthDay News) -- A new sealant to protect against leakage of cerebrospinal fluid after brain surgery has been approved by the U.S. Food and Drug Administration.
The DuraSeal dural sealant system is applied over stitches following dura mater surgery. The dura mater is the outermost, fibrous membrane that covers the brain and spinal cord. Leakage of cerebrospinal fluid can lead to serious complications, including severe headaches, infection, and meningitis, the FDA said in a statement announcing the approval.
The FDA said the new product, made by Confluent Surgical Inc., of Waltham, Mass., is the first device specifically designed to seal dura mater incisions. At present, surgeons must use other methods to prevent leakage, including "oversewing" tissue immediately surrounding the surgical site.
DuraSeal was evaluated in 111 patients at 10 hospitals in the United States and one in Europe, the agency said. The FDA said it recommended that the manufacturer conduct a post-approval study comparing the new device to current post-operative methods.
To learn more about brain surgery, visit the National Library of Medicine.