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 May 16, 2006 FOR IMMEDIATE RELEASE CENTERS FOR MEDICARE & MEDICAID SERVICES REVERSES PROPOSED NON-COVERAGE DETERMINATION FOR CHARITÉ™ ARTIFICIAL DISC RAYNHAM, MA – May 16, 2006 – The Centers for Medicare & Medicaid Services (CMS) has announced that they will reverse its proposed non-coverage determination for the CHARITÉ Artificial Disc and now allow for coverage at the discretion of the local Medicare medical directors for patients aged 60 and under. This decision means that these Medicare patients will continue to have access to the CHARITÉ Artificial Disc for single-level degenerative disc disease from L4 to S1. “This reversal signals recognition that the CHARITÉ Artificial Disc has an important role in treating the right patients,” said Gary Fischetti, President, DePuy Spine, Inc. “As we have consistently indicated, this technology is most appropriate for younger patients and this decision allows access to the disabled population who qualify for Medicare – and may benefit from this technology.” In the U.S. IDE clinical trial comparing artificial disc replacement to spinal fusion surgery, CHARITÉ Artificial Disc patients maintained flexibility, experienced improvements in pain and function, left the hospital sooner and were more satisfied with the procedure. Complication rates for both groups of patients were similar. More than 5,000 patients have received the disc in the U.S. since its U.S. Food and Drug Administration (FDA) approval in 2004. The CHARITÉ Artificial Disc is 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 and twist. 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. “We hope this decision will provide further support to other insurers of the importance of the CHARITÉ Artificial Disc as a treatment option for patients with degenerative disc disease,” said Richard Toselli, MD, DePuy Spine, Vice President, R&D. The CHARITÉ Artificial Disc offers clinical advantages when implanted by highly trained surgeons in carefully selected patients. DePuy Spine reports that additional data and analysis on outcomes will become available later this year. While patients have to meet selection criteria to be eligible for the procedure, patients experiencing severe back pain should ask their doctors to see if artificial disc replacement is appropriate for them. As with any surgery, there are some possible complications that can occur with disc replacement surgery with the CHARITÉ™ Artificial Disc. Complications can occur singly or in combination and may include: allergic reaction to the implant materials; bladder problems, bleeding, which may require a blood transfusion, infection and continued pain. Visit www.charitedisc.com for more information. 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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