Paradigm Spine announced that its coflex Interlaminar Stabilization device received a supplemental FDA pre-market approval (PMA) and coverage policy recommendation from the North American Spine Society (NASS), two developments that could assist adoption of a novel product that has faced reimbursement hurdles.
Paradigm Spine was granted a PMA for the coflex Interlaminar Stabilization disposable instrument kit. This marks the first approved disposable spinal instrument set for a Class III spinal device to receive a supplemental PMA.
Per FDA.gov, the supplement grants approval to introduce a kit of disposable instruments for coflex, and for Otto Klumpp to manufacture these disposable instruments in Germany.
The PMA will help Paradigm Spine target outpatient and ambulatory surgical center settings. More than a handful of spine players have launched disposable instruments in the last two years in light of the kit’s reduction of financial and operational burdens on facilities. Paradigm Spine’s kit will include a complete set of injection molded instruments delivered in a pre-sterilized peel pack.
The company also announced that NASS issued a coverage policy recommendation for Lumbar Interlaminar Device without Fusion and with Decompression. This is significant for coflex, as the recommendation provides payors with evidence to allow access for the technology.
coflex’s original PMA was granted in 2012 for the treatment of moderate to severe stenosis with or without back pain. Paradigm Spine secured a CPT code to cover coflex effective January 2017. The code was granted after five-year follow-up demonstrated long-term, sustained therapeutic effect of coflex vs. fusion in the treatment of LSS.
The International Society for the Advancement of Spine Surgery, Blue Cross Blue Shield of Michigan and Highmark have noted positive coverage recommendations for coflex. The recent NASS announcement recommends use of the device to treat lumbar spinal stenosis, and only applies to devices used with a direct decompressive procedure. To date, coflex is the only device that satisfies these conditions.