The Valeo implant is intended for vertebral body replacement to aid in surgical correction and stabilization of the thoracolumbar spine. The company said that Valeo VBR incorporates its novel silicon nitride ceramic, which provides new functionalities compared to competing devices currently in the market. The implant is designed to restore the biomechanical integrity of the anterior, middle and posterior spine, even in the absence of fusion, for a prolonged period of time.
Ashok Khandkar, CEO of Amedica, said: “We are very pleased to have received this FDA clearance of our innovative silicon nitride ceramic Valeo VBR implant. This is an important milestone for Amedica and we remain on track as we progress toward the expected launch of our lead Valeo products in the first half of 2008.”