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News Flash: Lumbar Artificial Disc to Hit the Market Soon
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Posted on: 02/28/2006
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The Food and Drug Administration (better known as the FDA) has given pre-approval for the release of a new artificial disc device. Designed by the Synthes, Inc. company the new disc is called the ProDisc-L. It has been tested for use in the lumbar spine from L3 to S1 for patients with degenerative disc disease (DDD).
The ProDisc-L was tested on a group of 292 patients with single level DDD. Measures of pain, motion, and disability were tested. Patients were followed for two years with good results. The ProDisc-L is already on the market in Europe and Asia. It's expected to be approved for use in the United States sometime this year.
Final approval is pending the FDA inspection of Synthes, Inc's manufacturing plant located in Brandywyne, Pennsylvania. Researchers are already studying this new disc device for use in two or more (multi-level) lumbar levels. The ProDisc-L offers patients an alternative to lumbar fusion...one that preserves motion.
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References:
New Artificial Disc Awaiting Final FDA Approval. In Orthopedics Today. February 2006. Vol. 26. No. 2. Pp.4.
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