Amedica Submits Clinical Data to FDA for Clearance of Silicon Nitride Composite Interbody Spinal Device
Amedica Corp. recently announced that it has submitted to the U.S. Food and Drug Administration (FDA) the 24-month clinical data outcomes from its CASCADE study, a blinded, randomized clinical trial that compared outcomes of cervical fusion between Amedica’s composite silicon nitride devices manufactured with an integrated core of cancellous structured ceramic (CsC), to the existing standard (i.e., polyether ether ketone plastic, or PEEK) spacers filled with bone autograft. The CASCADE study enrolled patients in a prospective trial that independently scored fusion rates and clinical outcomes at 24 months. The study was designed to compare the effects of Amedica’s porous silicon nitride vs. bone autograft on patient outcomes. The silicon nitride interbody device was wetted with blood from the surgery site, but had no extrinsic bone graft material added to it. The control group was a PEEK cage filled with bone autograft harvested during the decompressive discectomy. Results showed comparable clinical and radiographic performance between porous silicon nitride and bone autograft through a number of validated scientific clinical outcome measures.
“Porous silicon nitride is the first synthetic material to demonstrate spinal fusion outcomes that are similar to the patient’s own bone,” said Dr. Sonny Bal, chairman and CEO of Amedica. “These outcomes are consistent with our investigations of the surface chemistry and nano-topography of silicon nitride. This 24-month data has been submitted to the FDA in support of our application seeking clearance to commercialize our composite cervical interbody fusion device. Achieving clearance for this product is very important to us, as it furthers our mission to improve patient health through the enhancement of clinical outcomes for those patients who utilize our products, which is why we invested the necessary time in data gathering and analysis to ensure that we had it right before FDA submission.”
Pursuant to Section 510(k), the FDA has 90 days in which to either clear the Class II medical device for commercial distribution or to seek additional information. The FDA previously confirmed that it would review the product as a medical device. Following notification of FDA clearance, the company would immediately have the right to commence manufacturing, marketing, and sales of the product in the U.S. and its possessions subject to FDA jurisdiction.
For more information, visit www.amedica.com.