Vertos Medical receives CMS broad coverage approval for mild procedure: 5 key notes


Aliso Viejo, Calif.-based Vertos Medical received approval for expanded access through CMS' Coverage with Evidence Development Program for the mild procedure.

Here are five things to know:


1. Mild is an outpatient procedure designed to treat patients with lumbar spinal stenosis. The procedure doesn't require general anesthesia or implants.


2. The mild procedures has more than 20 peer-reviewed publications and 12 trials showing clinical effectiveness. More than 20,000 patients have undergone the procedure.


3. Medicare patients will now have broad access to the mild procedure via the CMS-approved claims analysis study that will collect and analyze real-world data to examine how the procedure performs in Medicare patients with lumbar spinal stenosis.


4. CMS granted the new study after Vertos Medical completed a successful randomized controlled study: MiDAS ENCORE.


5. Around 10 percent of Americans have spinal stenosis and an estimated 2.4 million people will feel pain as a result of lumbar spinal stenosis by 2021, according to recent estimates.


"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, MD, PhD, director of evidence based pain medicine research and education at Cleveland Clinic.


He was an investigator for previous mild studies and has performed the procedure since 2010.


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