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FDA NEWS RELEASE

FOR IMMEDIATE RELEASE
P05-17
April 7, 2005

Media Inquiries: Julie Zawisza, 301-796-4540
Consumer Inquiries: 888-INFO-FDA


 

FDA Approves Sealant to Prevent Cerebrospinal Fluid Leaks After Brain Surgery

The Food and Drug Administration (FDA) today approved a new product to protect against leakage of cerebrospinal fluid (CSF) after brain surgery.

The DuraSeal Dural Sealant System is used in dura mater surgery and is applied over sutures (stitches) to prevent CSF fluid from leaking out of the incision site. The dura mater is the tough, outermost, fibrous membrane that covers the brain and spinal cord, and lines the inner surface of the skull. Leakage of CSF can lead to serious complications, such as severe headaches, infection, and meningitis.

"This product is unique because it is the first device specifically designed and studied to seal sutured dura mater incisions," said Dr. Daniel Schultz, Director of FDA's Center for Devices and Radiological Health.

Presently, s urgeons use a variety of approaches to make sure the surgical incision site doesn't leak spinal fluid. One method is to "oversew" the area, which means surgeons sew the stitches closer together in the tissues immediately overlying the surgical site. Some surgeons pack the area with other tissues from the patient, such as fat, muscle, or connective tissue.

DuraSeal was evaluated in 111 patients. The study involved ten hospitals in the United States and one in Europe. All 111 patients treated with DuraSeal showed no CSF leakage during the intra-operative assessment. The adverse events observed were consistent with the type and complexity of the surgery performed, and with the patients' medical conditions. There were nine patients (8.1%) who had a postoperative infection at the surgical site. An FDA advisory panel of outside experts recommended that the manufacturer conduct a post-approval study to further investigate infection rates associated with use of the device. The manufacturer will conduct a post-approval study comparing its device to the standard of care used in hospitals.

DuraSeal consists of synthetic absorbable sealant materials and an applicator to apply the sealant to the incision site. The sealant is composed of two solutions, a polyethylene glycol (PEG) ester solution and a trilysine amine solution. When mixed together, the solutions combine to form the sealant gel. The sealant is absorbed in approximately four to eight weeks, enough time to allow for healing.

DuraSeal Sealant System is manufactured by Confluent Surgical, Inc., in Waltham, Ma.

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