Treatment of Symptomatic Lumbar Internal Disc Disruption (IDD) With the Biostat® System

Inclusion Criteria: * Age 18 or older and skeletally mature. * Voluntarily signs the subject informed consent form and agrees to the release of medical information for purposes of this study (HIPAA authorization). * Physically and mentally able to comply with the protocol, including ability to read and complete required forms, and willing and able to adhere to the follow-up requirements of the protocol. * Chronic low back pain for at least 6 months. * Pretreatment baseline low back pain of at least 40 mm on a 100 mm visual analog scale. * Pretreatment baseline Roland-Morris Disability Questionnaire score of at least 9 on the 24-point questionnaire. * Leg pain, if present, is of nonradicular origin, i.e., not due to stimulation of nerve roots or dorsal root ganglion of a spinal nerve by compressive forces. * Leg pain, if present, does not extend below the knee and is no greater than 50% of low back pain as measured on a visual analog scale. If bilateral leg pain, the worst leg pain is no greater than 50% of low back pain. * Low back pain unresponsive to at least 3 months of nonoperative care, which may include bed rest, antiinflammatory and analgesic medications, chiropractic manipulations, acupuncture, massage, physical therapy or home-directed lumbar exercise program. * Diagnostic medial branch block or facet joint injection between 18 months and 2 weeks prior to the study procedure indicates no facet joint involvement. * Diagnosis of symptomatic lumbar (L1-L2 - L5-S1) internal disc disruption (IDD), which requires confirmation of discogenic pain at one or two contiguous levels through positive provocation discography performed between 18 months and 2 weeks prior to the study procedure using pressure manometry and identification of an adjacent nonpainful disc. The disc provocation studies must precisely demonstrate concordant pain (\<50 psi above opening pressure) and must demonstrate a fissure(s) in the outer one-third of the posterior or lateral anulus. Exclusion Criteria: * Cauda equina syndrome. * Active malignancy or tumor as source of symptoms. * Current infection or prior history of spinal infection (e.g., discitis, septic arthritis, epidural abscess) or an active systemic infection. * Previous lumbar spine surgery. * Evidence of prior lumbar vertebral body fracture. * Disc bulge/protrusion or focal herniation at the symptomatic level(s) \> 4 mm. * Presence of disc extrusion or sequestration. * Leg pain is greater than 50% of low back pain as measu…