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Ghassan Bejjani, M.D.

University of Pittsburgh Neurosurgeon Studying Substitute Brain Covering

PITTSBURGH, March 6, 2001 — A University of Pittsburgh neurosurgeon has begun a study to evaluate the use of a medical material created from pig intestines to substitute as a covering for the brain or spinal cord following trauma or surgery. The medical device is called Durasis™ Dural Substitute and is being studied to determine if it can be a good substitute for dura mater, is the toughest and most fibrous layer of tissue covering the brain and spinal cord.

"Following most craniotomy procedures, the dura mater requires repair or augmentation in order to stop leakage of cerebral spinal fluid and prevent infection," said Ghassan Bejjani, M.D., assistant professor in the department of neurological surgery at the University of Pittsburgh School of Medicine and principal investigator in the study. "The ideal substitute for dura mater has not been found despite over 100 years of experimentation using many types of biologic and non-living tissues."

The ideal dura mater substitute, according to Dr. Bejjani, must be non-toxic, easily suturable, non-permeable, have minimal elasticity and be readily available and inexpensive.

In laboratory studies, Durasis, made from the pig small intestinal submucosa, has been found to have many of the ideal material properties required for repairing and replacing dura mater.

"Over time, Durasis is expected to take on the cellular characteristics of surrounding dural tissue," said Dr. Bejjani. "In addition to forming a nonpermeable barrier, Durasis acts as a scaffold on which human tissue grows. As it becomes overgrown with cells, it is absorbed by the body."

The study, which has already enrolled several patients, will evaluate the safety of Durasis and assess any surgical complications including infections or cerebral spinal fluid leaks. The material, which is used in commercially available medical devices intended for general soft-tissue reinforcement, is manufactured by Cook Biotech, Inc. of West Lafayette, Ind.

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