Medical device company, LDR, recently announced that the U.S. Food and Drug Administration (FDA) has approved the sale and distribution of its artificial disc replacement product, Mobi-C Cervical Disc.
The device is the only product approved in the U.S. for use in one and two level disc replacement in the cervical spine.
According to Spine-health's article on the subject, "An artificial cervical disc is a device inserted between two cervical vertebrae after an intervertebral disc has been surgically removed in the process of decompressing the spinal cord or a nerve root."
Artificial disc replacement (ADR) can be an alternative to spine fusion for the right patients. (See Artificial Disc Replacement Candidates).
Prior to Mobi-C's FDA approval the U.S. Food and Drug Administration (FDA) approved two artificial discs for lumbar disc replacement: the CHARITÉ™ Artificial Disc (DePuy Synthes) and the PRODISC®-L Total Disc Replacement (DePuy Synthes). The FDA has also approved five artificial discs for cervical disc replacement: the PRESTIGE® Cervical Disc System (Medtronic), the ProDisc™-C Total Disc Replacement (DePuy Synthes), the BRYAN® Cervical Disc (Medtronic), the SECURE®-C Cervical Artificial Disc (Globus), and the PCM® Cervical Disc System (NuVasive).
Currently, spinal fusions are the most common surgical interventions used to eliminate pain in the spine due to disc disease. Fusions work by eliminating movement at the painful level of the spine.
As an alternative to spinal fusion, ADR may offer two key benefits:
- It allows for continued mobility of the spine which eliminates stress to the discs above and below the fusion
- It uses bone-sparing technology (screws, rods, and sometimes grafts are required for spine fusions, but they are not required for ADR).
If you are considering spine fusion, don't forget to ask your surgeon about all of your options.