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March 19, 2007 FOR IMMEDIATE RELEASE NEW STUDY SHOWS PAIN RELIEF, MOBILITY, LOWER COMPLICATION RATE AND LOWER RATE OF ADJACENT LEVEL DISEASE WHEN COMPARED TO FUSION PATIENTS IN STUDIED GROUP OF CHARITÉ® DISC PATIENTS RAYNHAM, MA, March 19, 2007 - A new study published in the March 15 issue of Spine shows that the majority of patients who were implanted with the CHARITÉ Artificial Disc by the study's author between 1989 and 1995 continue to have less pain and more mobility as much as 16 years after the procedure. The retrospective study examined the safety and effectiveness of the CHARITÉ Disc in 108 patients operated on by Thierry David, MD, orthopedic spine surgeon from the Department of Orthopaedics Polyclinique De Bois Bernard, Rouvroy, France. The studied patients all had one-level (either at L4 - L5 or L5 - S1) lumbar degenerative disc disease and had failed non-operative treatment. Patients were followed for a minimum of ten years and up to 16.8 years. The study reports that 87 (82.1%) patients experienced "excellent or good" clinical outcomes, prosthesis mobility was 90.6% and that nearly 90% of patients eligible to work before surgery returned to work, more than three-quarters to hard labor. The average range of motion (ROM) in flexion-extension was 10.1 degrees and lateral bending was 4.4 degrees. "The patients in this series continue to do well after many years," said Dr. David. "The results are encouraging since it's been more than 10 years since these patients had an implant and since then the instrumentation and techniques to implant the disc continue to evolve, as has the criteria for patient selection." Dr. David reported in the study that, "the rate of post-operative complications is certainly lower than fusion if transition syndrome (or adjacent level disease) is considered a complication of fusion." The rate of adjacent level disease requiring surgical intervention was about 10-times lower (2.8%) for CHARITÉ Disc patients compared with some reports on the incidence of transition syndrome in the literature for lumbar fusion. In addition, the overall rate of re-operation was 10.4%, which included eight index-level fusion procedures and three prosthesis replacements. "The reduction in adjacent level disease may be the most interesting finding as it helps support the primary reason why I believe in total disc replacement," said Dr. Fabien Bitan, Chief of Spine Surgery at Lenox Hill Hospital in New York City who consults for DePuy Spine. "Adjacent level disease as a result of fusion is something that sometimes gets overlooked and, if possible, needs to be dramatically reduced by the spine community. Total Disc Replacement instead of fusion is one way to try and do that." More than 200,000 lumbar spinal fusion procedures are performed each year in the U.S. There were 63 females and 45 males in the study with an average age at the time of surgery of 36.4 years (age range 23 - 50). Eighty-two patients were treated at L5 - S1 and 25 at L4 - L5 and one at L3 - L4. A single case of core failure occurred at 9.5 years following surgery. Laboratory analysis indicated that shear forces and a high level of oxidation were likely contributors to this failure. The polyethylene cores of all CHARITÉ Discs sold in the U.S. since the device became available for commercial distribution are sterilized using DePuy's proprietary Gamma Vacuum Foil process, which is designed to reduce the incidence of on-shelf oxidation. All patients were seen for clinical follow-up by the treating surgeon at three and six months and at one, five, 10 and 15 years (10 patients) following surgery. The CHARITÉ Artificial Disc was the first artificial disc approved by the FDA. It was approved for sale in the U.S. in October 2004 and iterations have been available worldwide for more than 17 years. The CHARITÉ Artificial Disc is indicated for spinal arthroplasty in skeletally mature patients with degenerative disc disease (DDD) at one level from L4-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients should have no more than 3mm of spondylolisthesis at the involved level. Patients receiving the CHARITÉ Artificial Disc should have failed at least six months of conservative treatment prior to implantation of the CHARITÉ Artificial Disc. As with any surgical procedure, disc replacement surgery has risks. Individual patient results may vary and are not indicative of all outcomes. Patients should consult a trained spine surgeon to determine whether this procedure is right for them. 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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