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[December 2007]
Amedica Receives FDA Special Clearance for Ceramic Spinal Implant
Amedica Corporation, an orthopaedic implants company focused on silicon nitride ceramic technologies, has just announced that the U.S. Food and Drug Administration (FDA) has granted a Special 510(k) marketing clearance for Amedica's Valeo™ ceramic VBR spinal implant.The Valeo VBR spinal implant is intended for vertebral body replacement to aid in surgical correction and stabilisation of the thoracolumbar spine. The Valeo VBR incorporates Amedica's novel silicon nitride ceramic, which provides new functionalities compared to competing devices currently on 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.
"This is an important alternative to spine implants made from titanium and PEEK, as well as bone grafts taken from human cadavers," said Dr Darrel Brodke, Associate Professor in the Department of Orthopaedic Surgery, University of Utah School of Medicine, and Chief of the Spine Service and Medical Director of the University Spine Center. "The ceramic Valeo VBR implants uniquely combine strength with bone apposition, and simultaneously provide the visualization compatibility necessary for medical diagnostic imaging."
"We are very pleased to have received this FDA clearance of our innovative silicon nitride ceramic Valeo VBR implant," said Dr Ashok Khandkar, CEO of Amedica Corporation. "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."
ENDS