Vertos’ mild Receives Broad Coverage From CMS
Elizabeth Hofheinz, M.P.H., M.Ed. • Wed, March 15th, 2017
Vertos Medical Inc., headquartered in Aliso Viejo, California, is announcing the receipt of national coverage for its mild procedure through a recently approved study under the Centers for Medicare & Medicaid Services' (CMS) Coverage with Evidence Development (CED) Program.“mild is an outpatient treatment for lumbar spinal stenosis [LSS] that has been studied in more than 20 peer-reviewed publications and 12 clinical trials, and has been performed on more than 20,000 patients,” says the March 7, 2017 news release.
"Patient and physician demand for the mild procedure has grown a great deal, and I'm excited to hear that my patients and fellow practitioners will now have access to this effective, proven method for relieving pain and getting people back to doing the things that make life enjoyable," said Nagy Mekhail, M.D., Ph.D., director of Evidence Based Pain Medicine Research and Education at Cleveland Clinic, who is an investigator of previous clinical studies of mild and has been performing the procedure since 2010. "Neurogenic claudication related to lumbar spinal stenosis can be extremely life limiting; this first-line treatment stands to benefit the many patients currently being treated for LSS in the United States, who have no viable treatment options."
"This is great news for the thousands of people who suffer from the debilitating symptoms related to their lumbar spinal stenosis with neurogenic claudication, who have struggled to find a safe, effective, low-cost solution," said Eric Wichems, president and CEO of Vertos Medical.
Wichems told OTW, “mild is a clinically proven outpatient procedure performed through a portal the size of a baby aspirin, requires no stitches, no general anesthesia, no implants, and no overnight hospital stay. Efficacy has been demonstrated in more than 12 clinical studies and data demonstrate that mild allows patients to stand longer and walk farther with less pain. In the Cleveland Clinic study, at 1 year, patient standing time increased from 8 to 56 minutes and walking distance increased from 246 ft. to 3,956 feet.There were low complication rates, and mild has been clinically demonstrated to have a similar adverse event rate to epidural steroid injections (ESI). No serious device-related adverse events have been reported in any clinical trial.”
“Over two million patients are in active treatment for lumbar spinal stenosis in the United States with 95% of them not receiving surgery. mild is an ultra-minimally invasive, fluoroscopically-guided interventional procedure that is designed to provide relief of neurogenic claudication symptoms for the large number of patients not currently getting surgery.”