The North American Spine Society (NASS) has issued a coverage policy recommendation for Lumbar Interlaminar Device without Fusion and with Decompression, which applies to Paradigm Spine’s coflex device. This recommendation is particularly significant for coflex because it provides the evidence private health insurance companies require to allow access for patients to benefit from this technology.
The policy recommendations cover the use of spinous interlaminar devices, in conjunction with a direct decompression procedure. However, the only FDA approved, on-label device that currently matches this product class is coflex. The coflex device, as described by Paradigm Spine, is the exclusive lumbar motion preservation solution with proven long-term outcomes for durable pain relief and stability for patients with moderate to severe lumbar spinal stenosis.