Medicare Slightly Expands Coverage For Spine Procedure, But Policy Remains Trial-Limited
Vertos Medical asked the US Medicare agency to reconsider its 2014 decision that limits coverage of percutaneous image-guided lumbar decompression for lumbar spine stenosis to certain clinical trials. The agency ruled Dec. 7 that it will stick with the trial-limited policy, but expanded it to include longitudinal studies.
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New professional consensus guidelines recommend Vertos Medical’s minimally invasive lumbar decompression (MILD) system as an alternative to epidural steroid injections for patients with lumbar stenosis. The company is planning to raise more capital to expand its commercial operation so it can reach more patients that could benefit from MILD.
A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. This week, Vertos Medical gains a CE mark for its spine stenosis procedure kit, and US approvals for BD and Saranas.
The Medicare agency is reconsidering coverage of percutaneous image-guided lumbar decompression for lumbar spine stenosis in response to a request by device manufacturer Vertos. The firm's goal is to lift current clinical trial conditions for coverage of the procedure.