A Select Health of South Carolina clinical policy, dated 1 September, 2018, has been issued for the exclusive coverage of the coflex interlaminar stabilisation device (Paradigm Spine) for the treatment of lumbar spinal stenosis in patients meeting certain eligibility criteria.
Traditional surgical treatment options for lumbar spinal stenosis (LSS) include a decompression that removes bone and soft tissue and may also require a fusion to stabilise the spine. The coflex device is a non-fusion stabilisation implant that is FDA PMA approved for the treatment of lumbar spinal stenosis and is used in conjunction with a decompression, or used in lieu of a spinal fusion.
Marc Viscogliosi, Paradigm Spine chairman & CEO, commented, “This payor coverage adds to our growing momentum, enabling expanded access to our unique coflex solution, which is backed by more than 90 peer-reviewed published articles, including landmark long-term follow-up clinical studies, and coverage policy recommendations from spine medical societies.”
On 1 November, 2018, Paradigm Spine entered into a definitive agreement with RTI Surgical, whereby RTI will acquire all outstanding equity interest in Paradigm Spine. RTI has expressed its commitment to continue building coflex into a therapy of choice for orthopaedic surgeons given its demonstrated value and effectiveness for patients.