VertiFlex won reimbursement coverage from the Centers for Medicare & Medicaid Services for the company’s Totalis direct decompression system for treatment of spinal stenosis.
San Clemente, Calif.-based VertiFlex works on minimally invasive devices for treating lumbar spinal stenosis, a leading cause of spinal surgery in the elderly. The Totalis direct decompression system is comprised of a set of minimally invasive surgical tools used for the decompression of the lumbar spine. The device was cleared by the FDA in November 2012.
Under the terms of the coverage, Totalis will be available to patients who are in enrolled in an approved under "Coverage with Evidence Development," providing reimbursement for approved clinical trial patients.
“We are very pleased with the decision of CMS to allow CED for this very promising technology. There now exists a pathway for reimbursement for PILD procedures and Totalis for Medicare beneficiaries. We appreciate CMS’ leadership in allowing Coverage with Evidence Development, and look forward to working with them to finalize a robust clinical trial protocol,” president and CEO Earl Fender said in prepared remarks.