New implant aims to prevent repeat disc herniations

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subject is between 18 and 75 years old. * Posterolateral disc hernia between levels L4 and S1 with radiological (CT scan or MRI) confirmation of neural compression. * At least six weeks of failed conservative treatment prior to surgery, including physical therapy, use of anti-inflammatory medications at maximum specified dosage and/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 the clinical 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 of the 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 device implantation. * Endplate irregularities that, in the judgment of the surgeon, could affect the device implantation. * Prior surgery at the index lumbar vertebral level that, in the judgment of the surgeon, 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 women and patients receiving long-term treatment with corticosteroids) who present a bone densitometry DXA (dual energy x-ray absorptiometry) T-score of less than -2.0 at the index 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-treated malignancies 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 for surgery. * Patients who have received medication (e.g., methotrexate, alendronate) that interferes with bone mineral metabolism within 4 weeks of the planned date of the index 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 in any other interventional clinical study.