News Flash: Lumbar Artificial Disc to Hit the Market SoonThe 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.
New Artificial Disc Awaiting Final FDA Approval. In Orthopedics Today. February 2006. Vol. 26. No. 2. Pp.4.
|*Disclaimer:* The information contained herein is compiled from a variety of sources. It may not be complete or timely. It does not cover all diseases, physical conditions, ailments or treatments. The information should NOT be used in place of visit with your healthcare provider, nor should you disregard the advice of your health care provider because of any information you read in this topic.|
|All content provided by eORTHOPOD® is a registered trademark of Medical Multimedia Group, L.L.C.. Content is the sole property of Medical Multimedia Group, LLC and used herein by permission.|