A minimally invasive back pain treatment known as the mild procedure has now been approved to be sold and marketed throughout Europe. Over 12,000 patients have already received the treatment in the United States since it was approved by the Food and Drug Administration in 2008.
The mild procedure is designed to alleviate pain and increases mobility for patients suffering from lumbar spinal stenosis (LSS), which is caused by a narrowing of the spinal column due to age and deterioration. LSS causes a compression of the nerves in the spinal canal known as neurogenic claudication. The mild procedure relieves the compression by restoring space in the spinal canal through an incision the size of a baby aspirin.
Developed by Vertos Medical, mild is performed on an outpatient basis, does not require general anesthesia or stitches, and has a reported success rate of nearly 80 percent.
Vertos received the CE Mark this summer, which means it has complied with all legal and safety requirements to sell its mild device kit in 30 European countries.
“We are excited to be one step closer to bringing mild to the European market where we know there is a great deal of pent up demand for it,” said Vertos Medical CEO James Corbett. “Mild has helped thousands of patients stand longer and walk farther with less pain in the U.S. ”
A study published in Pain Practice earlier this year found that patients who underwent the mild procedure had significantly better pain reduction and improved mobility compared to the more standard treatment with epidural steroid injections.
The double-blind, randomized, prospective study was conducted at a pain management center. Thirty-eight patients with low back pain were divided into two groups. At 6 and 12 week intervals, the patients who underwent the mild treatment reported better pain reduction and increased mobility.
Multiple trials and several peer reviewed journal articles appear to have drawn similar conclusions.
According to the authors of a recent Cleveland Clinic study, the results suggest that the mild procedure was both safe and provided long term effectiveness in helping relieve pain for people suffering with lumbar spinal stenosis.
After monitoring 40 patients over a one-year, post-treatment period, researchers found that standing time for mild patients increased on average from eight minutes to nearly an hour, and that the patients’ average walking distance increased from 246 feet to nearly three quarters of a mile.
“This study demonstrated significant functional improvement as well as decreased disability,” the authors wrote. “There were no significant device or procedure-related adverse events reported in this study.”
Degenerative lumbar spinal stenosis is a common disease of the lumber spine with symptom generally beginning at 50 to 60 years of age. As many as 1.2 million Americans may have it. Although not life threatening, it can severely limit activity and cause chronic pain. Patients with LSS report numbness in the lower back, buttocks or upper legs, as well as reduced mobility.