ALISO VIEJO, Calif., March 7, 2017 /PRNewswire/ -- Vertos Medical, a medical device company committed to developing innovative, minimally invasive treatments for lumbar spinal stenosis (LSS), has received 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. A clinically proven outpatient procedure performed through a portal the size of a baby aspirin, mild requires no stitches, no general anesthesia, no implants, and no overnight hospital stay.
Broad access to the mild procedure has been granted for Medicare patients via a CMS-approved claims-analysis study that will passively collect and analyze real-world data to demonstrate the role of the therapy in the continuum of care for LSS. CMS's recent decision to expand access follows the successful completion of the company's CMS-approved randomized controlled study, MiDAS ENCORE.1
"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."
It is estimated that roughly 10% of Americans have lumbar spinal stenosis, and that by 2021 some 2.4 million will be experiencing considerable pain as a result of the condition.
"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.
The mild procedure has been studied in more than 20 peer-reviewed publications and 12 clinical trials, and has been performed on more than 20,000 patients. Peer-reviewed clinical data has demonstrated that mild helps patients suffering from LSS stand longer and walk further with less pain.2
1 Benyamin, R., et al. (2016). mild® is an Effective Treatment for Lumbar Spinal Stenosis with Neurogenic Claudication: MiDAS ENCORE Randomized Controlled Trial. Pain Physician, 19: 229-242. ISSN 1533-3159.
2 Mekhail, Nagy, et al. (2012). Functional and Patient-Reported Outcomes in Symptomatic Lumbar Spinal Stenosis Following Percutaneous Decompression. Pain Practice, 12(6): 417–425. doi: 10.1111/j.1533-2500.2012.00565.x.
Vertos Medical Inc. is a medical device company committed to developing innovative, minimally invasive treatments for lumbar spinal stenosis (LSS). Its proprietary technologies include mild®, which offers a safe, outpatient, minimally invasive, fluoroscopically guided therapeutic LSS treatment that requires no general anesthesia, no implants, and no stitches. LSS is primarily a degenerative, age-related narrowing of the lower spinal canal that causes symptoms of pain and numbness in the lower back, legs, or buttocks. mild® treats this condition by restoring space in the spinal canal using specialized mild® devices to remove hypertrophic ligamentum flavum through a 5.1-mm treatment portal. Clinical studies show that mild® can help LSS patients stand longer and walk farther with less pain1, and no major device-related complications have been reported in any clinical trial.2 Vertos Medical headquarters is located in Aliso Viejo, CA. To learn more about how mild® treats LSS click here.
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SOURCE Vertos Medical