Treatment of Symptomatic Lumbar Internal Disc Disruption (IDD) With the Biostat® Disc Augmentation System: A Pilot Study

Inclusion Criteria: * Age 18-75 (inclusive) 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. * 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. * Referred leg pain, if present, is of noncompressive origin and there are no clinical findings of radiculopathy. * Low-back pain is greater than leg pain (if present) as measured on a visual analog scale. If bilateral leg pain, back pain is greater than worst leg pain. * Low-back pain unresponsive to at least 6 weeks of nonoperative treatment, which may include bed rest, antiinflammatory and analgesic medications, chiropractic manipulations, acupuncture, massage, physical therapy or home-directed lumbar exercise program. * Negative response to diagnostic medial branch block or facet joint injection. * No sustained relief with epidural injection of corticosteroids. * 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 using pressure manometry and identification of an adjacent normal 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. * Infection at the planned procedure site or active systemic infection. * Previous lumbar spine surgery. * Previous disc invasive treatment procedures at the affected level(s) (e.g., intradiscal electrothermal therapy, intradiscal radiofrequency thermocoagulation) in the past 12 months or intradiscal corticosteroid injection within the past 3 months. * Evidence of prior lumbar vertebral body fracture or trauma. * Disc bulge/protrusion at the symptomatic level(s) \> 4 mm. * Presence of disc extrusion or sequestration. * Clinical findings of lumbosacral motor or sensory radiculopathy. * Leg pain is greater than low-back pain as measured on a visual analog scale. * Lumbar intervertebral foramen stenos…