Prestige LP Cervical Disc

Approval order statement

APPROVAL FOR THE PRESTIGE® LP CERVICAL DISC. THIS DEVICE IS INDICATED IN SKELETALLY MATURE PATIENTS FOR RECONSTRUCTION OF THE DISC AT ONE LEVEL FROM C3-C7 FOLLOWING SINGLE-LEVEL DISCECTOMY FOR INTRACTABLE RADICULOPATHY (ARM PAIN AND/OR A NEUROLOGICAL DEFICIT) WITH OR WITHOUT NECK PAIN, OR MYELOPATHY DUE TO A SINGLE-LEVEL ABNORMALITY LOCALIZED TO THE LEVEL OF THE DISC SPACE AND AT LEAST ONE OF THE FOLLOWING CONDITIONS CONFIRMED BY IMAGING (CT, MRI, X-RAYS): HERNIATED NUCLEUS PULPOSUS, SPONDYLOSIS (DEFINED BY THE PRESENCE OF OSTEOPHYTES), AND/OR VISIBLE LOSS OF DISC HEIGHT AS COMPARED TO ADJACENT LEVELS. THE PRESTIGE® LP CERVICAL DISC IS IMPLANTED USING AN ANTERIOR APPROACH. PATIENTS SHOULD HAVE FAILED AT LEAST 6 WEEKS OF NON-OPERATIVE TREATMENT OR HAVE HAD THE PRESENCE OF PROGRESSIVE SYMPTOMS OR SIGNS OF NERVE ROOT/SPINAL CORD COMPRESSION IN THE FACE OF CONTINUED NON-OPERATIVE MANAGEMENT PRIOR TO IMPLANTATION OF THE PRESTIGE® LP CERVICAL DISC.