Amedica Responds to FDA on Clearance of Silicon Nitride Spinal Device
Amedica Corp. recently announced that it has submitted its responses to the FDA in relation to the CASCADE clinical trial.
Amedica Corp. recently announced that it has submitted its responses to the U.S. Food and Drug Administration (FDA) in relation to the CASCADE clinical trial. The CASCADE study compared the 24-month outcomes from single-level cervical fusion between Amedica’s porous silicon nitride vs. bone autograft. Data showed that porous silicon nitride achieved clinical and radiographic outcomes that were comparable to bone autograft.
“Porous silicon nitride is a synthetic platform that can achieve spinal fusion without added bone graft, based on the results of our clinical trial,” said Sonny Bal, Ph.D., chairman and CEO. “These outcomes are consistent with our understanding of the surface chemistry and nano-topography of silicon nitride. We believe the composite porous silicon nitride fusion device used in the CASCADE trial, if approved by the FDA, will improve patient health. We are confident that we have addressed the questions raised by the FDA.”
The company anticipates a final determination from the FDA within the next 60 days. If approved, the company would commence manufacturing, marketing and sales of the product in the U.S. and its territories subject to FDA jurisdiction.
For more information, visit www.amedica.com.