The coflex® Interlaminar Technology is an Interlaminar Stabilization™ device indicated for use in one or two level lumbar stenosis from L1-L5 in skeletally mature patients with at least moderate impairment in function, who experience relief in flexion from their symptoms of leg/buttocks/groin pain, with or without back pain, and who have undergone at least 6 months of non-operative treatment. The coflex® is intended to be implanted midline between adjacent lamina of 1 or 2 adjacent lumbar motion segments. The Interlaminar Stabilization™ device is implanted after decompression of stenosis at the affected level(s).
Based on the FDA clinical study that has been published with 5 year follow-up data, when compared to the standard of care (fusion surgery), patients receiving the coflex® device experienced:
The coflex® device consists of a single, U-shaped component, made from medical-grade titanium alloy, a material with a long history of safe use in implantable orthopedic products. In clinical use, the “U” is positioned horizontally, with its apex oriented anteriorly and the two long arms of the “U” paralleling the long axis of the spinous processes. The bone-facing surfaces are ridged to provide resistance to migration.
Protection of Posterior Elements