A recent observational study examined the safety of mild ("Minimally Invasive Lumbar Decompression" by Vertos Medical Inc.) by doing a retrospective review of 90 patients treated with the procedure between January 2008 and July 2009. Researchers found no serious complications with the mild devices or technique, concluding that mild was as safe as or safer than similar spinal stenosis treatments.
The study was published in the January/February 2010 issue of the peer-reviewed journal Pain Physician and represents survey data collected from 12 U.S. centers. Physicians reviewed the charts of 90 patients with lumbar spinal stenosis, looking for problems that occurred during or right after the mild procedure and before discharge.
After reviewing patient survey results, researchers concluded that there were no reports of serious complications, which could include dural puncture or tear, blood transfusion, nerve injury, epidural bleeding, or hematoma. After comparing this data to previously published studies on alternative procedures, the study authors found that mild appears to be as safe as or safer than similar procedures for the treatment of lumbar spinal stenosis.
Spinal stenosis results from the gradual degeneration of the bones, discs, muscles, and ligaments that make up the spine, and is often a result of aging. The term "stenosis" literally means "choking," which is appropriate as the condition is characterized by the compression of either the spinal cord in the neck (cervical spine) or spinal nerve roots in the lower back (lumbar spine). The most common symptoms associated with lumbar spinal stenosis include leg pain, weakness, and tingling or numbness that radiate from the lower back down through the legs.
Non-surgical treatment options for lumbar spinal stenosis commonly include exercise, activity modification and epidural steroid injections. The decision to have surgery for lumbar spinal stenosis usually depends on the degree of physical disability and disabling pain. Patients who have stopped responding to pain medications and other conservative treatments may be considering surgery - mild is marketed as a less invasive surgery. Other surgical options include X-Stop, laminectomy or microdiscectomy, and spinal fusion.
The mild procedure uses special surgical instruments to remove the bone or tissue causing pressure on the nerves through a hole about the diameter of a pencil. The procedure can be performed in an outpatient setting under local anesthesia, and patients are often discharged the day following the procedure. Vertos mild has FDA 510K clearance for treating central canal stenosis of the lumbar spine.
Deer T, et al. New image-guided ultra-minimally invasive lumbar decompression method: the mild procedure. Pain Physician 2010; 13:35-41.