Amedica earns FDA clearance for Valeo C+CSC with Lumen Interbody Fusion Device — 5 notes

Surface Technology

The FDA cleared Amedica's Valeo C+CsC with Lumen Interbody Fusion Device.

Here are five notes:

 

1. Amedica's device is a composite spinal fusion implant featuring various densities of the company's proprietary medical grade silicon nitride ceramic.

 

2. The company manufactured a silicon nitride shell around a porous core, Cancellous structured Ceramic.

 

3. The CASCADE clinical trial found CsC is able to achieve s spinal fusion without added bone grafts. Additionally, CsC has success rates in line with bone autograft.

 

4. The Valeo C+CsC with Lumen Interbody Fusion Device is designed for cervical intervertebral body fusion.

 

5. The device is already approved in Europe.

 

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