Safety and Performance of Disc Care to Prevent Lumbar Disc Herniation Recurrence

Inclusion Criteria:

• Subject is between 18 and 75 years old.

• Posterolateral disc hernia between levels L4 and S1 with radiological (CT scan orMRI) confirmation of neural compression.

• At least six weeks of failed conservative treatment prior to surgery, includingphysical therapy, use of anti-inflammatory medications at maximum specified dosageand/or administration of epidural/facet injections.

• Minimum posterior disc height of 5 mm at the index level.

• Radiculopathy with positive straight leg raise test.

• ODI score of at least 30/100.

• Subjects who are able to give voluntary informed consent to participate in theclinical investigation and from whom consent has been obtained.

• Subject is able and willing to comply with the protocol requirements.

Exclusion Criteria:

• Spondylolisthesis and/or instability at the index level that, in the judgement ofthe surgeon, could affect the device implantation.

• Central, foraminal or extraforaminal disc hernia.

• Subject has vertebral bodies of the index level affected by any traumatic,neoplastic, metabolic, or infectious pathology.

• Subject has scoliosis of greater than 20 degrees (both angular and rotational).

• Grossly distorted anatomy due to congenital abnormalities.

• Deformation that affects the posterior corners of the vertebra at the index level (e.g., osteophytes) that, in the judgment of the surgeon, could affect the deviceimplantation.

• Endplate irregularities that, in the judgment of the surgeon, could affect thedevice implantation.

• Prior surgery at the index lumbar vertebral level that, in the judgment of thesurgeon, could affect the device implantation.

• Radiological confirmation of severe facet joint disease or degeneration.

• Patients diagnosed or at a high risk of osteoporosis (such as postmenopausal womenand patients receiving long-term treatment with corticosteroids) who present a bonedensitometry DXA (dual energy x-ray absorptiometry) T-score of less than -2.0 at theindex level.

• Cauda equina syndrome.

• Fever, leucocytosis and/or systemic or localized active infection.

• Systemic inflammation and/or inflammation at the implantation site.

• Any uncontrolled metabolic bone disease that affects the spine.

• Uncontrolled insulin-dependent diabetes mellitus.

• Peripheral neuropathy.

• Active hepatitis, AIDS or HIV.

• Rheumatoid arthritis or other autoimmune disease that affects the spine joints.

• Active or history of any invasive malignancy; patients with curatively-treatedmalignancies who have been disease-free for at least 5 years are eligible.

• Uncontrolled active tuberculosis or history of uncontrolled tuberculosis in the past 3 years.

• Immunologically suppressed patients.

• Current anticoagulation therapy, unless anticoagulation therapy can be suspended forsurgery.

• Patients who have received medication (e.g., methotrexate, alendronate) thatinterferes with bone mineral metabolism within 4 weeks of the planned date of theindex surgery.

• Suspected or known allergies or intolerance to the device materials: titanium,nitinol, stainless steel, polyetheretherketone and polyethylene terephthalate.

• Any condition that precludes the use of general anaesthesia.

• Any condition that precludes the surgical procedure.

• Any contraindication for MRI or CT scan.

• Class III obesity: Body mass index ≥ 40.

• Current alcohol or recreational drug dependency.

• Pregnant or interested in becoming pregnant in the following 24 months.

• Breastfeeding.

• Life expectancy less than 2 years.

• Subject is currently participating or has participated in the previous 4 weeks inany other interventional clinical study.