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| | | ![]() FDA Approves Adcon-L for Post-Surgical Scarring and Adhesions CLEVELAND, OH -- May 28, 1998 -- The United States Food and Drug Administration has granted marketing approval to Gliatech Inc.’s Adcon(R)-L, designed to inhibit post-surgical scarring and adhesions following lumbar surgery. Based on the most recent statistics available, in 1995, approximately 450,000 lumbar disc surgeries were performed in the U.S. Scarring and adhesions occur as part of the natural healing process but can be problematic after surgery if the adhesions form around the tissues, nerves and organs causing them to bind and tether to each other and the surrounding tissues. Results from the European clinical trial for Adcon-L demonstrated that the product significantly reduced the incidence of post-surgical scarring and adhesions and the incidence of post-operative activity-related pain. "Patients benefit from Adcon-L treatment through reduced scarring and adhesions resulting in less activity-related pain. Adcon-L is a much-needed product in this area," said Joseph Maroon, M.D., investigator in the Adcon-L study and chairman of the department of neurosurgery at Allegheny General Hospital in Pittsburgh, PA. Adcon-L adhesion control in a barrier gel is a proprietary resorbable gel, classified as a medical device, that provides a physical barrier to post-surgical adhesions involving the nerve roots of the spine. The product is applied by the surgeon at the surgical site and is naturally resorbed by the body. To date, Adcon-L has been used in approximately 12,000 surgeries world-wide and is available in 29 countries outside of the U.S. More information on: Adcon-L and Gliatech Inc.
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