The Amedica Corporation recently released the results of its 24-month level 1 trial for the CASCADE composite silicon nitride fusion device, which has a central, cancellous ceramic core. The device provided similar fusion and NDI outcomes when compared with a PEEK and autograft device after spinal fusion procedures.
Mark Arts, MD, PhD, the principal investigator of the study, presented the results of the clinical trial. The prospective, randomized clinical trial included 50 patients in each group. One cohort received the CASCADE composite silicon nitride fusion device, and the other cohort received the Medicrea Manta PEEK cage.
The 24-month NDI outcomes (the primary study outcome) were statistically similar between the cohorts. The fusion rates were similar between the cohorts as well, Arts said in a press conference.
“The findings of the CASCADE clinical trials show that the NDI and fusion were equivalent between groups at 24-months follow-up. The cancellous silicon nitride fused as well as the autograft. The composite silicon nitride defies the need for bone graft as well. The imaging of silicon nitride is also better than PEEK,” Arts said at the conference.
The CASCADE device is undergoing the FDA 510(k) submission process.