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Amedica secures FDA approval for expanded Valeo II lateral lumbar sizes

Amedica has secured approval from the US Food and Drug Administration (FDA) for additional Valeo II lateral lumbar interbody fusion device offerings.

The additional sizes of the Valeo II LL interbody fusion device will be commercially available from 29 August 2016.

Amedica says that the interbody fusion device, Valeo II has been made using its medical grade silicon nitride ceramic – which it claims to be an ideal material to be used in fusion because osteoconductivity, anti-infective properties, bone-like imaging (artefact free and radiotranslucent) and high strength.

The system has second generation instrumentation that can improve patient safety and ease of use for surgeon.

The new size of the implant allows the product to be used for patients falling under a wide range of anatomies. Amedica claims that the implant has greater stability as its weight is distributed over larger surface area.

The implant has been designed to have aggressive teeth for resistance expulsion, knurls for additional stability and thread insertion feature for precision implant control. Apart from this, two central cavities have been maximised for optimal bone graft packing.

The implant is particularly useful for intervertebral body fusion of the spine in skeletally mature patients and is designed to be used with autograft that enables fusion.

Amedica chairman and CEO Sonny Bal said: "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."