Lumbar spinal stenosis (LSS) is primarily a degenerative, age-related narrowing of the lower spinal canal that results in compression of the nerve roots and subsequent neurogenic claudication symptoms. Neurogenic claudication symptoms include pain, tingling, and numbness in the lower back, legs, or buttocks that worsen with lumbar extension (standing or walking) but improve with lumbar flexion (sitting or bending forward). It has been reported that as many as 94% of LSS patients have neurogenic claudication.4 The narrowing is caused by degenerative changes in the lumbar spine and is often multi-factorial in nature. Common co-factors include disc bulge, osteophytes, and ligamentum flavum hypertrophy. Conservative symptom management is often the first course of treatment, but if symptoms persist or get worse, a decompression procedure is required to alleviate the compression of the nerve roots.
Decompression treatment options, historically, were limited to invasive, high-risk, open surgical procedures including laminotomy or laminectomy with or without fusion that result in changes to the structural stability of the spine. Now there is mild, a safe, outpatient, minimally invasive, fluoroscopically guided therapeutic treatment that can help LSS patients stand longer and walk farther with less pain.1 mild is performed through a 5.1 mm treatment portal that requires no general anesthesia, no implants, and no stitches. mild safely decompresses the spinal canal by removing small portions of lamina and hypertrophic ligamentum flavum leaving the structural stability of the spine intact.
Once the hypertrophic ligamentum flavum has been debulked, the space is restored in the spinal canal and clinical studies have demonstrated that around 80% of patients experience a significant reduction in pain and improvement in standing time and walking distance even in the presence of other LSS causal factors.1 mild has been studied in over 11 clinical studies and positive outcomes have been published in more than 16 peer-reviewed journal articles. The procedure has been performed on over 15,000 patients. No major device-related complications have been reported in any clinical trial.2
mild key safety features
Fluoroscopically Guided to Ensure Continuous Safety:
• Visualization of the instruments and treatment area before and during the procedure
• All activity is posterior to the dura
• No general anesthesia required
• Small incision – 5.1 mm (size of a baby aspirin)
• No stitches
• No implants
Low Complication Rate:
• No dural tears, nerve root damage or blood loss requiring transfusion reported in clinical trials2
• Adverse event rate <0.1% in more than 15,000 commercial cases
mild proven long-term efficacy
Functional Outcome Improvement Cleveland Clinic Study at One Year:1
• Standing time increased from 8 minutes before treatment to 56 minutes post-mild at one year
• Walking distance increased from 246 feet before treatment to 3,956 feet post-mild at one year
Long-term Efficacy Meta-Analysis Study at One Year:5
• Pain reduced in 81% of patients
o Mean pain reduced by 53% (VAS 3.9 pt. imp.)
o Mean mobility increased by 34% (ODI 16 pt. imp.)
Important Safety Information
Although the complication rate for the mild procedure is low, as with most surgical procedures, serious adverse events, some of which can be fatal, can occur, including heart attack, cardiac arrest, stroke, and embolism. Other risks include infection and bleeding; spinal cord and nerve injury that can, in rare instances, cause paralysis. This procedure is not for everyone. Physicians should discuss potential risks with patients. For complete information regarding indications for use, contraindications, warnings, precautions, adverse events, and methods of use, please reference the devices’ Instructions for Use.