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The U.S. Food and Drug Administration (FDA) has approved the CHARITÉ™ Artificial Disc, a device that treats severe low back pain by replacing a damaged or worn out spinal disc with an artificial one. The approval was announced October, 2004 by the manufacture, DePuy Spine, Inc., a subsidiary of Johnson & Johnson.
While artificial replacements are commonly used in hips and knees, this is the first FDA approval of such a device for spinal discs.
The CHARITÉ™ Artificial Disc is made of two metallic endplates and a movable high-density plastic center. Once implanted, it 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 Lumbar fusions performed each year in the U.S.
The Boston Spine Group participated in clinical trials 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.
Artificial disc replacement is not for everyone. As with any major surgery, there are possible complications that can occur including unresolved pain, allergic reactions, bladder problems and/or infection. Patients should ask their doctors to see if artificial disc replacement is appropriate for them.
Currently, The Boston Spine Group is one of only a few spine centers throughout the U.S. who offer disc replacement with the CHARITÉ™ Artificial Disc. Many more centers are expected within the next several months as surgeons receive extensive training in the procedure. The Boston Spine Group is proud to be participating in the training of surgeons across the United States. |
