First artificial disc for low-back pain treatment approved
The Food and Drug Administration has approved the first artificial disc for lower back pain.
The CHARITE Artificial Disc replaces a damaged or worn out spinal disc with an artificial one to alleviate lower back pain, a procedure not unlike hip replacement surgery, according to experts.
This use of this new device, which is made by DePuy Spine, Inc., would be the first spine treatment that would preserve motion while still relieving pain, said Scott Blumenthal, M.D., leader of the national investigational study of 304 cases.
The artificial disc is made of two metallic endplates and a movable high-density plastic center that is designed to perform and move like the body's own spinal disc, according to the company.
Lumbar spinal fusion, the most common procedure for low back pain or degenerative disc disease, can limit the range of possible motion and put extra stress on other spinal discs. More than 200,000 fusion procedures are performed each year.
The FDA advised that patients are only eligible if they have degenerative disc disease and have not had back pain alleviation in over six months. Officials advised DePuy Spine to conduct another study to determine the device's long-term safety and effectiveness, as well as its impact on other spinal discs.