HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs

Inclusion Criteria: * Male or female subjects aged 22 to 85 years, inclusive * Subjects presenting with LBP greater than leg pain and symptoms of DDD of the lumbar region (L1- S1) of at least six (6) months duration * Presence of one (1) or two (2) symptomatic disc(s) (i.e., only 1-level or 2-levels may be treated during the study) as determined by Discography * Symptomatic disc(s) exhibiting Grade 4 to 8 degeneration on the modified Pfirrmann scale as determined by MRI * Failure to have their symptoms resolve or reduce following at least six (6) months of conservative care (as defined in the body of the protocol) * Psychosocially, mentally and physically able and willing to fully comply with this protocol including adhering to follow-up schedule and requirements and filling out forms * English fluency * Signed informed consent Exclusion Criteria: * History of or active systemic or local infection * Any skin disease or inadequate tissue coverage at the site of the proposed injection * Annular tear or defect that shows free contrast extravasation into the epidural space during or after Discography * Presence of more than two (2) symptomatic discs presenting with pain confirmed during Discography * Presence of extruded or sequestered disc herniation (i.e., disc extrusions or sequestrations) at the symptomatic level(s) or on adjacent levels * Presence of wide annular fissures confluent with large disc protrusions at the symptomatic level(s) * Epidural steroid injection, intra…