To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Advisory Panel Recommends Anti-Scarring Gel URL: http://www.pslgroup.com/dg/4DB86.htm Doctor's Guide December 15, 1997
WASHINGTON, MD -- December 15, 1997 -- The Orthopaedic and Rehabilitation Devices Advisory Panel for the Food and Drug Administration recommended that Gliatech Inc.'s premarket approval application to market Adcon(R)-L Anti-Adhesion Barrier Gel in the United States is approvable with conditions regarding labeling. The gel is the first product designed to inhibit undesirable scarring and adhesions following lumbar disc surgery. The advisory panel ruled that Adcon-L is safe and effective in inhibiting scarring and adhesions after lumbar disc surgery. The panel's decision was based on the review of safety and effectiveness data from both a pivotal European clinical trial and supplemental U.S. study involving more than 450 patients at 25 clinical sites. These clinical results demonstrated that Adcon-L significantly reduced the incidence of scar following lumbar disc surgery. The panel's recommendation, along with a final review of safety and effectiveness data and manufacturing compliance, will be considered by the FDA in its final review of Gliatech's premarket approval application for Adcon-L. The FDA is not bound by the decision of the panel, but it is customary for the FDA to follow the panel's recommendation. Adcon-L is a proprietary carbohydrate polymer gel that provides a physical barrier to postoperative adhesions between the spinal cord and nerve roots and the surrounding muscle and bone. Postsurgical scarring and adhesions occur when tissues and organs bind together following surgery. These adhesions can lead to recurrent back pain, impairment of function and poor surgical outcome. Of the more than 400,000 patients that have lumbar disc surgery each year in the U.S., up to approximately 40 percent experience recurrent back pain following surgery. In addition, five to 10 percent of these patients may require a reoperation which can be difficult for surgeons to perform and may lead to further complications for the patient during surgery if excessive scar is present. Adcon-L, which is applied by the surgeon at the surgical site, coats the intricate areas surrounding the spinal cord and nerve roots. It is naturally resorbed by the body within approximately four weeks, and thus, requires no surgical removal. Adcon-L is currently available in 31 countries outside of the U.S. and has been used to treat over 10,000 patients worldwide. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.