FDA approves PRESTIGE LP Cervical Disc System

Medtronic announced it has received approval from the U.S. Food and Drug Administration to market the PRESTIGE LP Cervical Disc System for the treatment of single-level cervical disc disease.

The system incorporates the same ball-and-trough articulation design used in the company’s original system, allowing the two components to move in a range of motions that include bending, rotation and translation. The design of the new system also incorporates two rails positioned off midline that are press-fit into two pre-drilled holes created during the surgical procedure, instead of using bone screws to attach the artificial disc to the vertebral bodies.

The system is indicated for skeletally mature patients who require reconstruction of the disc at one level from C3 to C7 following one-level discectomy for intractable radiculopathy with or without neck pain, or myelopathy due to one-level abnormality localized to the level of the disc space, according to a company press release. Patients must also have at least one of the following conditions confirmed on radiograph or CT: herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes) and/or visible loss of disc height compared with adjacent levels.

The PRESTIGE LP Cervical Disc System has been available outside the United States since 2004, according to the release.