New Cervical Disc Approved by FDA

cervical disc device approved fda

Medtronic's newly approved Prestige LP Cervical Disc.

The U.S. Food and Drug Administration approved a new artificial cervical spinal disc in late July to be used in disc replacement surgery to treat radiculopathy and/or myelopathy. The Prestige LP Cervical Disc can replace one diseased disc in the neck and is a titanium-ceramic alloy that fits between the top and bottom of the cervical vertebrae.

Medtronic are manufacturers of the device which is designed to be implanted between two vertebrae in the neck following the removal of a damaged or disease spinal disc. This artificial disc will help maintain the height between vertebrae and allow for rotation and bending of the spine.

Maintaining range of motion in the cervical spine is especially important as this is one of the most mobile sections of the spinal column. Discectomy and fusion can cause adjacent segment disease and problems with neck mobility and degeneration of the cervical spine and is more common in less mobile spinal regions such as areas of the lumbar spine.

Candidates for Artificial Spinal Discs

The Prestige LP Cervical Disc is only intended for use in adults undergoing discectomy at levels C3 to C7. It can help prevent collapse of the disc space and preserve range of motion in the neck. A study comparing the new disc to cervical fusion surgery found a 79.3% success rate compared to a 66.8% success rate over 24 months after surgery.

Anyone with osteoporosis or osteopenia, or who is suffering from an active infection should not undergo surgery and implantation of the artificial disc, nor should anyone with an allergy or sensitivity to titanium, aluminium or vanadium. People with instability of the cervical spine are also considered poor candidates for use of the Prestige LP Cervical Disc, as are those with severe spondylosis at the site of surgery, or problems across multiple levels of the cervical spine.

Facet joint disease, pseudoarthroses, spinal trauma and deformity resulting from inflammatory diseases like ankylosing spondylitis or rheumatoid arthritis may also prevent the use of this newly approved artificial cervical spinal disc.

Recovery After Artificial Disc Replacement

Removing a diseased disc in the neck can help relieve pressure on the spinal nerves and spinal cord, resulting in reduce nerve pain and symptoms of radiculopathy and myelopathy, such as weakness and numbness. In some cases, especially where appropriate treatment was delayed, nerve damage may be permanent and symptoms may not resolve effectively even after discectomy and the implantation of an artificial disc.

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