Amedica receives FDA clearance for additional lateral lumbar interbody fusion device sizes

Amedica Corporation announced it has received FDA clearance for expanded Valeo II lateral lumbar sizes.

According to the release, the fusion device is made of Amedica’s medical-grade silicon nitride ceramic. The system reportedly includes second-generation instruments that may improve patient safety and surgeon ease of use.

“I am delighted to announce the recent FDA clearance of our expanded silicon nitride lateral lumbar implant offerings,” B. Sonny Bal, MD, JD, BMA, chairman and chief executive officer of Amedica, said in the release. “It is estimated that lateral lumbar procedures will remain one of the fastest growing interbody fusion segments over the next 5 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 our individuals.”

The additional sizes will reportedly allow for greater stability, with the shape of the implant distributing weight over a larger surface area. According to the release, the additional sizes for the Valeo II lateral lumbar interbody fusion device will become commercially available on Aug. 29, 2016.

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