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.