MiDAS II (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study

Exclusion Criteria

• •Prior surgery at intended treatment level.
• •Compound fracture with interspinal retropulsion contributing to spinal stenosis.
• •Disabling back or leg pain from causes other than LSS (e.g. acute compression fracture, metabolic neuropathy, or vascular claudication symptoms, etc.).
• •Disc protrusion or osteophyte formation severe enough to confound study outcome.
• •Facet hypertrophy severe enough to confound study outcome.
• •Bleeding disorders and/or current use of anti-coagulants.
• •Use of acetylsalicylic acid (ASA) and/or non-steroidal anti-inflammatory drug (NSAID) within 5 days of treatment.
• •Epidural steroid administration within prior three weeks (of procedure).
• •Inability of the patient to lie prone for any reason with anesthesia support (e.g.chronic obstructive pulmonary disease (COPD), obesity, etc.).
• •Metabolic wound healing pathologies deemed by Investigator to compromise study outcomes.
• •Dementia and/or inability to give informed consent.
• •Pregnant and/or breastfeeding.
• •On Workman's Compensation or considering litigation associated with back pain.