PLAINSBORO, N.J., Dec. 4, 2006 (PRIME NEWSWIRE) (PRIMEZONE) -- Integra LifeSciences Holding Corporation (Nasdaq:IART) announced the first patient surgery as part of the FDA approved Investigational Device Exemption (IDE), to conduct a clinical trial designed to evaluate the safety and effectiveness of DuraGen Plus(R) Adhesion Barrier Matrix for use in spinal surgery. The surgery was performed by Harry Lockstadt, M.D. of Bluegrass Orthopedics in Lexington, Kentucky.
"The surgery went smoothly, following a routine lumbar discectomy," said Dr Lockstadt. "If DuraGen Plus(R) proves effective as an adhesion barrier in the spine, it could benefit my patients and be a welcome addition to my surgical practice."
There are approximately 450,000 lower back surgical procedures in the U.S. each year and spinal adhesions, or scarring, can occur as a result of surgery. Frequently, this scarring presses on surrounding nerve tissue and causes radiating, or radicular pain, requiring additional surgery. Integra estimates that the total available worldwide market for treatment of spinal adhesions exceeds $300 million.
"Spinal adhesions are a frequent and often troublesome consequence of spine surgery," said Professor Edward Benzel, M.D., Chairman of the Spine Institute at The Cleveland Clinic, and principal investigator for the clinical trial. "The potential relationship between post-operative radicular pain and scarring from spinal adhesions presents a significant challenge to clinicians. I look forward to participating in this clinical trial and await the results."
DuraGen Plus(R) Adhesion Barrier Matrix has been designed to provide a prophylactic treatment option for the prevention of adhesions, by protecting the nerve root from post-operative scar formation. The randomized, multi-center clinical trial will be conducted at 30 investigational sites and include 500 patients. It will evaluate the safety and effectiveness of the DuraGen Plus(R) Matrix as an adhesion barrier, compared to a control group, in spine surgery procedures, by measuring the extent of peridural fibrosis and radicular pain over a one year follow up period.
"An unmet need exists for a safe and effective adhesion barrier matrix for spinal applications," said Simon Archibald, Ph.D., Integra's Chief Scientific Officer. "We believe such a product would be greeted with enthusiasm by the surgeon community."
Integra LifeSciences Holdings Corporation is a diversified medical technology company that develops, manufactures, and markets medical devices for use in a variety of applications. The primary applications for our products are neurosurgery, reconstructive surgery and general surgery. Integra is a leader in applying the principles of biotechnology to medical devices that improve patients' quality of life. Our corporate headquarters are in Plainsboro, New Jersey, and we have manufacturing and research facilities located throughout the world. Please visit our website at (http://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(R) Plus 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 section of Integra's Annual Report on Form 10-K for the year ended December 31, 2005, and information contained in subsequent filings with the Securities and Exchange Commission, could affect actual results. CONTACT: Integra LifeSciences Holdings Corporation
John B. Henneman, III, Executive Vice President,
Chief Administrative Officer
(609) 936-2481
jhenneman@Integra-LS.com
Gianna Sabella, Public Relations Manager
(609) 936-2389
gsabella@Integra-LS.com
http://www.primezone.com/newsroom/news.html?d=109792
No comments:
Post a Comment