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Amedica Submits 2-Year Clinical Data for Clearance of Silicon Nitride Device -

Amedica (AMDA) submitted to FDA the 24-month clinical data from CASCADE, a blinded, randomized clinical trial comparing outcomes of cervical fusion between AMDA's composite silicon nitride devices to PEEK spacers filled with bone autograft, the standard of care.

Results showed comparable clinical and radiographic performance between porous silicon nitride and bone autograft through various validated scientific clinical outcome measures.

CASCADE enrolled patients in a prospective trial that independently scored fusion rates and clinical outcomes at 24 months, comparing the effects of porous silicon nitride vs. autograft. The silicon nitride interbody device, which features a cancellous structured ceramic core, 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 autograft. 

Results showed comparable clinical and radiographic performance between porous silicon nitride and bone autograft through various validated scientific clinical outcome measures.

AMDA had filed for FDA 510(k) clearance of the Valeo C Interbody device in 1Q15. A round of question-and-response followed in 2Q15, with FDA requesting 24-month CASCADE data in 3Q15. At that time, AMDA indicated that the requested data would be available in 4Q15, pushing the timeline for FDA's anticipated final response to late 4Q15 or early 1Q16.

FDA has 90 days to either clear the Class II medical device or seek additional information, and has previously confirmed that it would review the product as a medical device.

Source: Amedica Corporation

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