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 March 11, 2005 NEW STUDY SHOWS REVISION RATE LOWER WITH CHARITÉ™ ARTIFICIAL DISC THAN SPINAL FUSION Supplemental Posterior Fixation Preferred Method of Revision PHOENIX – March 11, 2005 – According to a new study, artificial disc replacement with the CHARITÉ™ Artificial Disc required fewer revisions than traditional anterior lumbar interbody spinal fusion (ALIF) surgery. The study was presented here at the 21st annual meeting of the AANS/CNS Section on Disorders of the Spine and Peripheral Nerves. In this multi-center prospective clinical trial of 688 patients, 375 or whom were randomized to receive either the disc or fusion, the rate of revision with the CHARITÉ Artificial Disc was 8.1 percent compared with 10.1 percent for BAK spinal fusion patients. The study, sponsored by DePuy Spine, Inc., a Johnson & Johnson company, was part of the company’s clinical submission that led to FDA approval of the CHARITÉ Artificial Disc for patients with single-level degenerative disc disease. The study found that 18 patients in the CHARITÉ Artificial Disc group needing a revision had supplemental posterior fixation, five were successfully revised by placement of another CHARITÉ Artificial Disc, and 13 were revised with an ALIF or 360 degree fusion. “Revision may be necessary in artificial disc replacement and traditional spinal fusion surgery. This study shows us that all the artificial disc replacement patients were able to be revised successfully either with a new prosthesis or with spinal fusion,” said Paul McAfee, MD of the Spine and Scoliosis Center in Baltimore who presented the study. The study concluded that the primary revision method should be supplemental posterior fixation. Removal of the device for replacement, or to perform a spinal fusion, is made possible by its design, which does not incorporate a keel implanted in the vertebral body like other investigational artificial disc devices. The CHARITÉ Artificial Disc is the only artificial disc approved by the FDA. The CHARITÉ Artificial Disc is a high-tech device made of two metallic endplates and a movable high-density plastic center that, once implanted, is designed to help align the spine and preserve its ability to move. Spinal discs maintain the position of the spine and allow for the flexibility to bend. Lumbar spinal fusion surgery, a common surgical treatment for low back pain or degenerative disc disease, is often effective in reducing pain, but limits range of motion and may transfer extra stress to discs above and below the fusion site. More than 200,000 of these procedures are performed each year in the U.S. Artificial disc replacement is not for everyone. As with any major surgery, there are possible complications that can occur including unresolved pain, allergic reactions, and/or infection. Patients should ask their doctors to see if artificial disc replacement is appropriate for them. The CHARITÉ Artificial Disc is also available in more than 30 countries throughout Europe, Asia, North America, Africa and Latin America. About DePuy Spine DePuy Spine, a Johnson & Johnson company, has worked and partnered with leading clinicians, researchers, and thought leaders to develop products to treat spine disorders for over 20 years. Today, DePuy Spine stands in the forefront of the worldwide spine market, with a substantial sales organization in the U.S. and an expanding worldwide distribution network. The company is committed to advancing the knowledge of all health care professionals and their patients in addressing spinal pathologies. |
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