Amedica Receives FDA Clearance for Interbody Fusion Device Sizes
Amedica Corp. recently announced the FDA clearance of expanded Valeo® II Lateral Lumbar sizes.
Amedica Corp. recently announced the U.S. Food and Drug Administration (FDA) clearance of expanded Valeo® II Lateral Lumbar sizes. The additional sizes of the Valeo II LL interbody fusion device became commercially available at the end of August.
The Valeo II LL interbody fusion device reportedly is entirely made of Amedica’s proprietary medical-grade silicon nitride ceramic, making the material good for fusion due to its osteoconductivity, anti-infective properties, bone-like imaging (artifact-free and radiotranslucent) and high strength. The system includes second-generation instrumentation to improve patient safety and ease of use for surgeons.
“I’m delighted to announce the recent FDA clearance of our expanded silicon nitride lateral lumbar implant offerings,” said Sonny Bal, Ph.D., chairman and CEO. “It’s estimated that lateral lumbar procedures will remain one of the fastest-growing interbody fusion segments over the next five years. The minimally invasive nature of the procedure provides patients with benefits such as less blood loss, smaller incisions and shorter hospital and intraoperative times. We believe these clinical benefits, coupled with our unique silicon nitride biomaterial, will lead to an improved continuum of care for individuals.”
The recently cleared sizes 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 for expulsion resistance, knurls for added stability, a threaded insertion feature for precise implant control, and two central cavities maximized for bone graft packing.
For more information, visit www.amedica.com.