A 5-year Superion™ IDS Clinical Outcomes Post-Approval Evaluation (SCOPE)
To compile real-world outcomes of the Superion™ IDS in routine clinical practice.
• 45 years of age or older when written informed consent is obtained
• 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).
• 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).
• Subject signed a valid, IRB-approved informed consent form (ICF) provided in English.
• 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.
• Able to independently read and complete all questionnaires and assessments provided in English