WEDNESDAY, Oct. 27, 2004 (HealthDayNews) -- The first artificial spinal disc for people with chronic lower back pain has been approved by the U.S. Food and Drug Administration.
The Charite artificial disc, made by Massachusetts-based DePuy Spine Inc., was approved for patients with degenerative disc disease (DDD) in the lumbar area of the spine. Qualifying patients should have had no relief from low back pain after at least six months of non-surgical treatment, the FDA said in a statement.
The artificial disc is comprised of a plastic core sandwiched between two metal endplates. It helps restore the natural distance between two vertebrae, following removal of a diseased disc. The device is installed under general anesthesia through a small incision just below the belly button.
The device was approved following 24-month trials at 16 medical centers involving 205 patients diagnosed with DDD. The agency is requiring the manufacturer to conduct a post-approval study of the device's long-term safety and effectiveness.
To learn more about lower back pain, visit the National Institute of Medicine.