Assessing Superion Clinical Endpoints vs. Decompression

Inclusion criteria

• ✓. Male or female subjects ≥ 45 years of age.
• ✓. Persistent leg/buttock/groin pain, with or without back pain that is consistently relieved by flexion activities (example: sitting or bending over a shopping cart).
• ✓. Subjects who have been symptomatic and undergoing conservative care treatment for at least 6 months, without relief.
• ✓. Diagnosis of degenerative spinal stenosis of the lumbar spine, defined as the narrowing of the midline sagittal spinal canal (central) and/or narrowing between the facet superior articulating process (SAP), the posterior vertebral margin (lateral access), and the nerve root canal (foraminal).
• ✓. Radiographic confirmation of at least moderate spinal stenosis which narrows the central, lateral, or foraminal spinal canal at one or two contiguous levels from L1-L5. Moderate spinal stenosis is defined as ≤50% reduction in lateral/central foramen.
• ✓. Must present with moderately impaired Physical Function (PF) defined as a score of ≥ 2.0 of the Zurich Claudication Questionnaire (ZCQ).
• ✓. Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
• ✓. Subjects, who, in the opinion of the Clinical Investigator, are able to understand this clinical investigation, cooperate with the investigational procedures and are willing to return for all the required post-treatment follow-ups.