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April 26, 2007 FOR IMMEDIATE RELEASE NINE STUDIES ON CHARITÉ® ARTIFICIAL DISC PRESENTED AT AANS/CNS JOINT SECTION MEETING RAYNHAM, MA, April 26, 2007 - The CHARITÉ® Artificial Disc, the first artificial disc approved by the U.S. Food and Drug Administration (FDA) three years ago for the treatment of single-level degenerative disc disease (DDD), was the subject of nine studies presented at the 23rd annual meeting of the AANS/CNS Joint Section on Disorders of the Spine and Peripheral Nerves held in Phoenix earlier this month. Ten-year experience data from outside the U.S., the difference in range of motion (ROM) between the CHARITÉ Disc and spinal fusion, and predicted survivorship of the disc, were among the studies presented. "The CHARITÉ Artificial Disc continues to be the subject of many studies that continue to suggest it is a safe and effective treatment that produces good clinical outcomes for carefully selected patients," said Matthew Scott-Young, MD, a spine surgeon at Pacific Private Clinic, Qoutport Queensland, Australia and author of three of the studies presented at AANS/CNS. In a study entitled, "Ten-Year Experience with One-Level Lumbar Arthroplasty," Dr. Scott-Young and his researchers conducted a retrospective chart review of 137 of his patients receiving a CHARITÉ Artificial Disc over a 10-year period, and reported that the overall clinical improvement in primary clinical measures was approximately 70 percent compared to baseline. Clinical outcomes were measured using ODI, VAS (back and leg), Roland-Morris, SF-36 questionnaires and work status. The revision rate was 2.9%. The mean follow-up was 32.6 months. Another study compared in vivo and in vitro range of motion after single-level disc arthroplasty with the CHARITÉ Disc to spinal fusion. Researchers led by Bryan W. Cunningham, MSc, Director of the Orthopaedic Spinal Laboratory, St. Joseph's Medical Center, Towson, MD, found that spinal fusion "greatly increases the in vivo ROM distribution at adjacent levels, confirming prior in vitro results and is a likely factor in rate or frequency of transition syndrome," and that "one-level arthroplasty replicates the normal distribution of motion of the intact spine at the implant and adjacent levels, confirming prior in vitro results." Paul C. McAfee, MD a spine surgeon from St. Joseph's Hospital in Towson, MD and other researchers found a "high rate of predicted survivorship of lumbar total disc replacement with the CHARITÉ Artificial Disc at both the implanted-level and the adjacent-level at 5 years vs. ALIF." According to the study, which was a retrospective chart review of 1938 patients at 8 sites in 5 countries, the five-year predicted survivorship of the CHARITÉ Disc (without revision, reoperation or removal) ranged from 91.6% (Brazil) to 96.2% (Korea), with an aggregate mean of 93.1%. ALIF with BAK cages had an aggregate mean of 80.1%, what the authors call "a highly significant difference." The predicted five-year survivorship for the adjacent levels in CHARITÉ Disc cases averaged 95.6% compared to 89.0% predicted survivorship for ALIF with BAK. The American Association of Neurological Surgeons (AANS) and the Congress of Neurological Surgeons (CNS) jointly sponsor the meeting where all these studies were presented. 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. #### (Source: DePuy Spine, Inc.) |
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