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COPYRIGHT 2004 International Medical News Group
CHICAGO -- The first artificial disk approved for use in the United States offers patients with chronic degenerative disk disease an alternative to spinal fusion surgery, but beware: Surgeons have a steep learning curve for placing the device correctly.
The primary advantage of the Charite Artificial Disc system by DePuy Spine Inc., a subsidiary of Johnson & Johnson, is that it offers pain relief, motion retention, and earlier return to normal function, Charite clinical trial investigator Scott Blumenthal, M.D., said in an interview.
The Charite disk, which was approved by the Food and Drug Administration in October, is indicated for patients with single-level degenerative disk disease. The device consists of two cobalt chromium end plates and a polyethylene core. There's no secondary bone graft harvesting or stabilizing of the spine with screws and rods, as in spinal fusion surgery. When implanted, the device restores the natural distance between two vertebrae and allows movement at the level of implantation. And unlike the strict limitation imposed on patients who have undergone fusion surgery, when the disk is implanted successfully, there are no movement restrictions, said Dr. Blumenthal of the Texas Back Institute, Plano.
The European experience with the Charite, which dates back 2 decades, suggests it also may reduce adjacent degenerative disease better than fusion surgery, although this hasn't been specifically evaluated in clinical trials.
The FDA is...
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