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First patients treated in lumbar spinal stenosis trial

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VertiFlex announced that the first patients have received treatment in a trial to evaluate the VertiFlex Totalis direct decompression system for the treatment of lumbar spinal stenosis.

The Study To Evaluate Percutaneous Image-Guided Lumbar Decompression (PILD) for Stenosis (STEPS) is a prospective, multicenter, randomized, double-blind trial comparing the use of the VertiFlex Totalis system and a simulated surgical procedure, according to a company press release. STEPS includes 20 interventional spine sites throughout the U.S. and is expected to enroll approximately 168 patients.

The purpose of the study is to provide level 1 evidence that PILD improves health outcomes and meets the Centers for Medicare and Medicaid Services (CMS)’ classification of “reasonable and necessary.”

Conducted in collaboration with CMS’ Coverage with Evidence Development guidance, STEPS is intended to help lay the groundwork for broad reimbursement coverage for the procedure, according to the release.

VertiFlex received 510(k) clearance for the Totalis system and has been commercially available in the United States since March 2013, the release said.

Reference: www.vertiflexspine.com.