VySpine has announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its LumiVy NanoVy Ti Lumbar IBF system which is indicated for intervertebral body fusion for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis.
The LumiVy NanoVy Ti Lumbar IBF system features VySpine’s NanoVy Ti coating technology in partnership with Implant Surfaces. NanoVy Ti is a titanium coating that is mere nanometers thick, adhered to a polyetheretherketone (PEEK) LumiVy implant. The NanoVy Ti coating is engineered to facilitate direct osteoblast attachment to the entire surface of the LumiVy implant.
According to VySpine, the high adhesion and impact resistant NanoVy Ti coating bonds intimately to the PEEK structure, and has been shown to increase expulsion resistance of the LumiVy implant. Furthermore, the NanoVy Ti technology does this without compromising the radiolucency, or favourable modulus of elasticity, of the PEEK material, add the company.
The LumiVy NanoVy Ti Lumbar IBF system is a robust, yet elegantly simple system. It is offered in a vast array of footprints for nearly any lumbar interbody approach. Additionally, it is available in a range of sizes, heights, and lordotic angles, adds the company.