Bryan Cervical Disc Prosthesis

Approval order statement

APPROVAL FOR THE BRYAN CERVICAL DISC. THE DEVICE IS INDICATED IN SKELETALLY MATURE PATIENTS FOR RECONSTRUCTION OF THE DISC FROM C3-C7 FOLLOWING SINGLE-LEVEL DISCECTOMY FOR INTRACTABLE RADICULOPATHY AND/OR MYELOPATHY.THE BRYAN DEVICE IS IMPLANTED VIA AN OPEN ANTERIOR APPROACH. INTRACTABLE RADICULOPATHYAND/OR MYELOPATHY IS DEFINED AS ANY COMBINATION OF THE FOLLOWING: DISC HERNIATION WITHRADICULOPATHY. SPONDYLOTIC RADICULOPATHY, DISC HERNIATION WITH MYELOPATHY, OR SPONDYLOTICMYELOPATHY RESULTING IN IMPAIRED FUNCTION AND AT LEAST ONE CLINICAL NEUROLOGICAL SIGN ASSOCIATEDWITH THE CERVICAL LEVEL TO BE TREATED, AND NECESSITATING SURGERY AS DEMONSTRATED USING COMPUTEDTOMOGRAPHY (CT), MYELOGRAPHY AND CT, AND/OR MAGNETIC RESONANCE IMAGING (MR1). PATIENTSRECEIVING THE BRYAN CERVICAL DISC SHOULD HAVE FAILED AT LEAST SIX WEEKS OF NON-OPERATIVE TREATMENT PRIOR TO IMPLANTATION OF THE BRYAN CERVICAL DISC.