FDA Clears Durasis® Dural Substitute
from Cook Biotech for U.S. Sales

West Lafayette, Ind. - The U.S. Food and Drug Administration has granted Cook Biotech Incorporated clearance to sell DURASIS® Dural Substitute in the United States. DURASIS, indicated for use as a dura substitute for repairing dura mater, had previously received CE Mark approval for sales in Europe.

Dura mater is the tough, fibrous sheath that surrounds the brain and spinal cord. Portions of the dura mater can be damaged by trauma or removed during neurosurgical procedures. Surgical repair and replacement of the dura mater is important to prevent infection and post-operative cerebrospinal fluid (CSF) leakage.

"We are very pleased to have received FDA clearance for this neurosurgical product," stated Mark Bleyer, president of Cook Biotech. "This clearance is the result of extensive collaboration with key neurosurgeons who helped design this product specifically to repair the unique tissue that covers the brain and spinal cord. Durasis has passed extensive, long-term, pre-clinical tests and has been further proven through a multi-centered clinical trial."

DURASIS utilizes Cook Biotech's innovative Small Intestinal Submucosa (SIS) technology, a collagen biomatrix that supports remodeling of host tissue. SIS is a natural biomaterial harvested from a specific portion of porcine (swine) small intestine and developed into strong, sterile, pliable sheets that provide a rich environment for cell attachment and growth. This tissue has been found to have many of the ideal material properties required for repairing and replacing dura mater. Over time, Durasis takes on the cellular characteristics of surrounding dural tissue while it serves as a scaffold on which human tissue grows. As the biomaterial is replaced with cells, the scaffold is no longer needed and it is absorbed by the body.

"Durasis is an ideal dural substitute," stated Ghassan Bejjani, M.D., clinical assistant professor in the department of neurological surgery at the University of Pittsburgh School of Medicine. "Durasis is easy to handle and suture, does not allow leakage of cerebrospinal fluid, has exceptional strength, is durable, and has the advantage of remodeling into native tissue." Dr. Bejjani was the principal investigator who coordinated the clinical trial for the Durasis product.

Cook Biotech (http://www.cookbiotech.com), a Cook company, is actively developing extracellular matrix (ECM) technology and biological scaffolds for numerous medical purposes. Medical products utilizing Cook's licensed and patented ECM technology are currently marketed worldwide for use in wound management and surgical repair of soft tissues. Together with a network of medical practitioners, Cook Biotech is identifying the medical needs most compatible with ECM technology and developing products to meet these needs.

With international headquarters in Bloomington, Ind., privately held COOK® (http://www.cookgroup.com) is a leading designer, manufacturer and global distributor of minimally invasive medical device technology for diagnostic and therapeutic procedures.

News Media Contact:

David McCarty, 812-339-2235, ext. 2387; dmccarty@cook-inc.com
Director of Public Relations, Cook Incorporated

Madia Milks, 765-497-3355, ext. 28; milks@cookbiotech.com
Marketing Communications Coordinator, Cook Biotech Incorporated

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