PLAINSBORO, N.J., Sept. 17, 2007 (PRIME NEWSWIRE) -- Integra LifeSciences Holding Corporation (Nasdaq:IART) is pleased to announce the poster presentation "Periradicular Lumbar Fibrosis: What to Do?" by Dr. Inaki Arrotegui, of the Department of Neurosurgery, University of Valencia General Hospital, Spain, at this year's College of Neurological Surgeons Annual Meeting in San Diego. The presentation will take place this Monday, September 17th at 4 p.m. PST. This retrospective review of 430 patients, who underwent surgery of the lumbar spine, demonstrated that the re-operation rate significantly decreased for the population of patients who received DuraGen(R) Dural Graft Matrix as an adhesion barrier. The reduction in re-operation rate translated to a cost benefit to the hospital. Duragen Plus(R) has received approval in the European Union and Canada as a dural graft and adhesion barrier and is called DuraGen Plus(r) Adhesion Barrier Matrix. Duragen Plus(R) Adhesion Barrier Matrix is an investigational device in the United States.
"Because the extent of fibrosis varies from patient to patient due to inflammatory response, vascular condition, and surgical approach, the development of an effective method for inhibiting postsurgical fibrosis is critical to achieving an optimal clinical result," said Dr. Arrotegui. "As DuraGen(R) does not inhibit the wound healing process in the event of an incidental durotomy, I have felt comfortable using DuraGen(R) as an adhesion barrier and have now done so in approximately 1000 patients in the last seven years."
Periradicular lumbar fibrosis may result in postsurgical pain for patients undergoing lower back surgery. Fibrosis is the development of excess connective tissue also known as spinal adhesions or scar. The scar, which occurs post-surgically as a result of the natural wound healing process, may, in some instances, press on surrounding nerve tissue and cause radiating pain in the leg. Integra estimates that the total available worldwide market for treatment of spinal adhesions exceeds $300 million.
"We are pleased that the highly respected Congress of Neurological Surgeons has accepted the poster presentation of Dr. Arrotegui's work on the reduction of periradicular fibrosis at this year's meeting in San Diego. There exists an unmet need for safe products to protect the nerve from scarring in the lumbar spine. With over 500,000 implantations to date as a duraplasty material for the brain and spine, the DuraGen(R) product line already has an extensive safety record. DuraGen Plus(R) Adhesion Barrier Matrix may be the only product CE Marked that has both the ability to repair the dura mater and the potential to protect the patient from radicular pain by inhibiting postsurgical fibrosis," said Simon Archibald, Ph.D., Integra's Chief Scientific Officer.
DuraGen Plus(R) Adhesion Barrier Matrix is CE marked in the European Union to provide a prophylactic treatment option for the prevention of adhesions by protecting the nerve root from post-operative scar formation. The product is not approved for use in the United States as an adhesion barrier. Integra is conducting a randomized, multi-center clinical trial in the United States under an Investigational Device Exemption (IDE) to evaluate the safety and effectiveness of the DuraGen Plus(R) matrix as an adhesion barrier in lumbar spine surgery.
Integra LifeSciences Holdings Corporation, a world leader in regenerative medicine, is dedicated to improving the quality of life for patients through the development, manufacturing, and marketing of cost-effective surgical implants and medical instruments. The company's products, used primarily in neurosurgery, extremity reconstruction, orthopedics and general surgery, are used to treat millions of patients every year. Integra's headquarters are in Plainsboro, New Jersey, and it has research and manufacturing facilities throughout the world. For more information visit www.Integra-LS.com.
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning the future clinical uses for the DuraGen Plus(R) Adhesion Barrier Matrix. Such forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from predicted or expected results. Among other things, the success of the multi-center clinical trial for the DuraGen Plus(R) product as an adhesion barrier in spinal surgery may affect the FDA's willingness to approve the product for sale in the United States. In addition, the economic, competitive, governmental, technological and other factors, identified under the Risk Factors included in IA of Integra's Annual Report on Form 10-K for the year ended December 31, 2006, and information contained in subsequent filings with the Securities and Exchange Commission, could affect actual results.
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