Amedica released the results of its CASCADE study (CAncellous Structured Ceramic Arthrodesis Device), a blinded, randomized clinical trial that compared outcomes of spinal fusion surgery using Amedica’s composite silicon nitride spacers (manufactured with a central core of cancellous structured ceramic) to the gold standard, PEEK spacers (polyether ether ketone plastic) filled with autograft bone.
CASCADE is the first study to show that a synthetic material, both in the porous and as-fired format, may heal and fuse as well as autograft. Specifically, the study results suggest that it is no longer necessary to use hollow interbody spacers filled with bone or bone void fillers to achieve fusion.
The study enrolled 104 patients in a prospective clinical trial that independently scored fusion rates and clinical outcomes at 12 months follow-up.
The incidence of cervical spine fusion was statistically identical between study groups, and consistent with figures reported in other studies. The trial used a more robust measure of fusion than is commonly accepted—specifically, a 2-degree change in flexion instead of a 5-degree change. Further, the silicon nitride composite device offered superior imaging characteristics in MRI and x-ray.
In the CASCADE clinical results presentation, Amedica CEO Dr. Sonny Bal stated:
“Spine surgeons here and in Europe have accepted the inadequacies of PEEK, as Dr. Arts highlighted, and a lot of spine companies/competitors are attempting to coat PEEK with titanium or hydroxyapatite; those are attempting to overcome the fact that plastic does not heal to bone. The industry will look at our product in a totally new way. We believe our silicon nitride technology is the ideal biomaterial for bone applications and bone fusion. It will allow surgeons to move away from using passive cages or spacers as bone filler-holding-devices to affect fusion.”
In January 2015, Amedica filed a submission for FDA 510(k) clearance of the Valeo C Interbody device with CsC Osteo-Conductive Scaffolding (Valeo C + CsC). Clearance or other notice is expected by 3Q15.