SeaSpine has announced the launch of its Cambria NanoMetalene cervical interbody body fusion device. It is designed for use as an adjunct to fusion in patients with degenerative disc disease, and for use in anterior cervical discectomy procedures. The device comprises an “ultra-thin” layer of commercially pure titanium, molecularly bonded to a PEEK-Optima implant. Applied in a proprietary high-energy, low-temperature surface process, it encompasses the entire implant, including the centre graft aperture.
James Bruffey, an orthopaedic spine surgeon in San Diego speaking during an NASS presentation, commented on the topic of bond strength of NanoMetalene. According to SeaSpine, he indicated that destructive testing as well as insertion and push-out testing demonstrated no delamination of the atomic deposition titanium surface.
According to a SeaSpine press release, the Cambria NanoMetalene offers the benefits associated with traditional PEEK-Optima devices such as a modulus of elasticity similar to bone and radiolucency for postoperative imaging. With a molecularly bonded titanium surface on an uncompromised PEEK-Optima implant, SeaSpine claims that it can provides customers with an interbody solution.
SeaSpine has received FDA 510(k) clearance for other NanoMetalene-coated PEEK interbody devices in its current portfolio and expects to continue launching additional products with this technology throughout the next year.