Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nuclectomy 3

Inclusion Criteria:

• Patient is skeletally mature and at least 21 years of age.

• Patient has a lumbar disc herniation, between L1-S1, with compressive radiculopathyof the traversing nerve root requiring partial discectomy or sequestrectomy. Onlyone lumbar disc may be treated with the PerQdisc device.

• Patient must have an overall disc herniation (extrusion or protrusion) such thathalf or less of the width of the dorsal annulus of the spinal canal, is affected bythe herniation. The width of the canal is defined by the lateral recesses and thecentral canal (i.e. pedicle to pedicle).

• Patient must have a minimum of 6 mm of disc height as measured in the center of theaffected disc.

• Patient is willing and able to give informed consent.

• All surgeries must be approved by at least 2 members of the Medical Advisory Board (MAB) - potential anatomical limitations of safely accessing Kambin's, extent ofannular disruption, as well as overall patient criteria will be evaluated

Exclusion Criteria:

• Patient has had prior lumbar spine surgery at the index level (nucleoplasy isacceptable).

• Patient has had spinal fusion in the lumbar spine. Cervical or thoracic fusion isallowed as long as there are no neurologic deficits in the lower extremities.

• Patient has spondyloarthropathy or other spondylolisthesis greater than 4 mm orspondylolysis at the index level (on standing X-ray).

• Patient has underlying moderate or severe spinal stenosis (congenital, degenerative,or due to epidural lipomatosis) at any level. If the index level shows stenosis dueto the disc herniation, it is acceptable if the index level is going to be treatedconcurrently with the PerQdsic procedure.

• Patient has compressive radiculopathy of the exiting nerve root at the index level.

• Patient has significant facet disease. Significant is defined as clinicallyconfirmed by diagnostic block or radiologically grade 2 or higher (mild jointnarrowing and irregularity are acceptable, but not sclerosis or osteophyteformation).

• Patient has any known active malignancy.

• Patient has previously undergone or currently on immunosuppressive therapy. Steroidsused to treat inflammation are allowed.

• Patient has active local or systemic infection.

• Patient has been diagnosed with hepatitis, rheumatoid arthritis, lupuserythematosus, or other autoimmune disease including AIDS, AIDS related complex (ARC) and HIV.

• Patient has diabetes mellitus (Type 1 or 2) requiring daily insulin management.

• Patient has osteopenia of the spine (T-score of -1.0 or lower). All patients 50years of age or older, and any post menopausal women with a history of fracturesshould have a dual x-ray absorptiometry (DEXA) scan to confirm exclusion.

• Patient has morbid obesity defined as a body mass index (BMI) more than 35 (>35).

• Patient has a known allergy to silicone or barium sulfate.

• Patient has a broad disc herniation that is wider than ½ of the dorsal annulusforming the wall of the spinal canal

• Patient requires decompression involving disruption of the midline bony-ligamentouselements (i.e. laminectomy).

• Patient has a significant Schmorl's node at the level to be treated, or anySchmorl's nodes affecting 3 or more lumbar levels. Significant is defined as alarge, rectangular or irregular shaped node that has an associated activeinflammatory process (Modic I changes).

• Patient has more than 20 degrees of mobility on flexion/extension radiographs at theindex level

• Patient has more than 10 degrees of lumbar scoliosis.

• Patient belongs to a vulnerable population or has a condition such that his/herability to provide informed consent, comply with follow-up requirements, or provideself-assessments is compromised (e.g. developmentally disabled, prisoner, chronicalcohol/ substance abuser)

• Patient is pregnant or plans to become pregnant during the course of the study.Pregnancy ruled out by serum HCG. If patient becomes pregnant during the course ofthe study and wishes to continue study participation, a new Pregnancy InformedConsent must be completed.

Intraoperative Exclusion:

• Poor radiological visualization of Kambin's triangle

• Patient has annular defect following surgical treatment of the discherniation/protrusion that is greater than 6 mm

• Sustained irritation of the exiting nerve root during any aspect of the annulardilation technique (leg movement or if performing with electrical monitoring) inspite of repositioning instruments.

• Protrusion of the 50A Imaging Balloon up to or beyond the outer margin of thevertebra during the imaging steps.

• Patient has a violated endplate as determined by imaging balloons duringfluoroscopy.