• Rate of revision surgery at the treated level [ Time Frame: 90 days ]
  Number of patients requiring surgeries to revise the implanted level in the spine divided by the total number of implant surgeries. Express in percentage (0-100)
• Rate of expulsion [ Time Frame: 90 Days ]
  The rate of device expulsion. The number of patients determined to have expulsed devices divided by the total number of patients receiving implants.Expressed in percentage (0-100)
• Rate of new herniation at the treated level as determined by MRI [ Time Frame: 90 days ]
  Herniation will be determine by MRI. A herniation will be defined as violation of the intervertebral annulus, including expulsion of nucleus material. The response will be yes/no as assessed by the radiologist. Rate will be determined by total number of herniations divided by the total number of implanted devices. Expressed in percentage (0-100)
• Rate of new radiculopathy [ Time Frame: 90 days ]
  New complaint of leg pain will be recorded as a yes/no response. Any complaint of new radiculopathy not seen preoperatively. Expressed as total number of new radiculopathy complaints divided by total number of patients. Expressed in percentage (0-100)
• MRI assessment of the endplate Modic changes. [ Time Frame: 90 days ]
  Changes to vertebral endplates will be assigned based on Modic classification of I,II or III comparing preoperative grade to grade at 90 days. Possible scores are I,II or III
• Rate of surgical procedure technical success [ Time Frame: 90 days ]
  The number of devices successfully implanted divided by the number of successfully devices implanted + unsuccessful implants. Output will be in percentage (0-100)
• Improvement in degree of disability as measured by the Oswestry Disability Index (ODI) [ Time Frame: 90 days ]
  Change in absolute Oswestry Index score at 90 days compared to the preoperative score, range is 0-100
• Improvement in back pain as measured by 10-centimeter Visual Analog Scale (VAS) [ Time Frame: 90 days ]
  Change in the Visual Analogue Scale (VAS) for back and leg pain on a scale of 0-10 cm comparing preoperative scores to 90 days post-operative.

• Rate of revision surgery at the treated level [ Time Frame: 90 days ]
  Composite Endpoint
• Rate of expulsion [ Time Frame: 90 Days ]
  Composite Endpoint
• Rate of new herniation at the treated level as determined by MRI [ Time Frame: 90 days ]
  Composite Endpoint
• Rate of new radiculopathy [ Time Frame: 90 days ]
  Composite Endpoint
• MRI assessment of the endplate modic changes [ Time Frame: 90 days ]
  Composite Endpoint
• Rate of surgical procedure technical success [ Time Frame: 90 days ]
  Composite Endpoint
• Improvement in degree of disability as measured by the Oswestry Disability Index (ODI) composite score. 0-100 scale [ Time Frame: 90 days ]
  Composite Endpoint
• Improvement in back pain as measured by 10-centimeter Visual Analog Scale (VAS) [ Time Frame: 90 days ]
  Composite Endpoint

• Degenerative Disc Disease
• Chronic Low-back Pain

Inclusion Criteria:

• Patient is skeletally mature and between 22 and 60 years of age.
• Patient has degenerative disc disease (DDD) at a single level between L1 and S1 as confirmed by:History and clinical findings suggestive of symptomatic DDD, Darkened disc on MRI in T2 weighted images, and decreased disc height (decreased greater than 2 mm compared to adjacent cranial or caudal disc height) with minimum disc height of 6 mm.
• Patient has pre-operative back pain VAS score of greater than or equal to 4 (0-10 scale).
• Patient has pre-operative Oswestry Low Back Disability score of greater than or equal to 40 (0-100 scale).
• Patient has received conservative (non-surgical) treatment for back pain for a minimum of 6 months.
• Patient has signed the approved Informed Consent Form.

Exclusion Criteria:

• Patient has had prior lumbar spine surgery.
• Patient has motion of less than 3 degrees on pre-operative lateral flexion/extension radiographs.
• Patient has ankylosing spondylitis or other spondyloarthropathy.
• Patient has isthmic spondylolisthesis or degenerative spondylolisthesis greater than 2 mm.
• Patient has congenital stenosis or epidural lipomatosis.
• Patient has significant facet disease.
• Patient has any known active malignancy.
• Patient has previously undergone immunosuppressive therapy.
• Patient has active local or system infection.
• Patient has been diagnosed with hepatitis, rheumatoid arthritis, lupus erythematosus, or other autoimmune disease, including AIDS, ARC and HIV
• Patient has diabetes mellitus (Type 1 or 2), requiring daily insulin management.
• Patient has osteopenia of the spine (T-score less than 1.0). All females 45 years of age or older and all males 50 or older should have a DEXA scan to confirm this exclusion.
• Patient has morbid obesity defined as body mass index (BMI) more than 40 or a weight of more than 45 kg (100 lbs) over ideal body weight.
• Patient is pregnant or plans to become pregnant during the course of the study.
• Patient has a known allergy to silicone (polymer and balloon material) or barium sulfate (polymer).
• Patient participated in another investigational drug or device study within the past 30 days.
• Patient belongs to a vulnerable population or has a condition such that his/her ability to provide informed consent, comply with follow-up requirements, or provide self assessments is compromised (e.g. developmentally disables, prisoner, chronic alcohol/ substance abuser)
• Patient has a disc herniation
• Patient has a Schmorl's node in the level to be treated

Intraoperative exclusion criteria:

• Protrusion of the 20A imaging balloon up to or beyond the outer margin of the vertebra during the imaging steps.
• Patient has a violated endplate.
• Patient has a disc space that is too narrow.