Amedica receives US FDA clearance for expanded Valeo II lateral lumbar interbody fusion device sizes


amedica-submits-response-to-fda-for-clearance-of-composite-interbody-spinal-deviceThe US Food and Drug Administration (FDA) has cleared an expanded range of Valeo II lateral lumbar sizes (Amedica). The additional sizes of the Valeo II LL interbody fusion device will be commercially available August 29, 2016.

The Valeo II LL interbody fusion device is made entirely of Amedica’s proprietary medical grade silicon nitride ceramic. The system includes second generation instrumentation intended to improve patient safety and surg
eon ease of use.

The new sizes are designed to allow for greater accommodation for a wide range of patient anatomies as well as greater stability as the shape of the implant distributes weight over a larger surface area. The design of the interbody fusion device consists of aggressive teeth intended for expulsion resistance, knurls to promote added stability, a threaded insertion feature for precision implant control, and two central cavities designed for optimal bone graft packing.

The Valeo II LL is indicated for intervertebral body fusion of the spine in skeletally mature patients and is designed for use with autograft to facilitate fusion.