Amedica Receives CE Mark For The World's First FDA-Cleared Valeo(TM) Ceramic Spinal Implant System

Main Category: Bones / Orthopaedics
Also Included In: Neurology / Neuroscience;  Regulatory Affairs / Drug Approvals
Article Date: 13 Nov 2008 - 0:00 PST

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Amedica Corporation, an orthopedic implants company focused on silicon nitride ceramic technologies, announced that it has received a CE (Conformite Europeene) mark for its Valeo(TM) family of ceramic spinal intervertebral spacers. This family includes Valeo - C and Valeo - TL spacers made using Amedica's novel silicon nitride ceramic for surgical correction or stabilization of the spine. This family received FDA clearance in January 2008, for sale in the United States as vertebral body replacements.

The Valeo family of ceramic spinal intervertebral spacers is intended to aid in surgical correction and stabilization of the thoracolumbar spine. These implants are 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. The Valeo family of spacers provides new functionalities compared to competing devices currently on the market and is believed to be the first family of silicon nitride ceramic implants available for spinal use in the world.

"Amedica's ceramic spinal spacers uniquely combine strength with an improved bone/implant interface and bone like imaging compatibility, making them a valuable alternative to currently available devices using conventional synthetic materials," said Darrel Brodke, M.D., Professor and Vice-Chair, Director of Spine Service, Department of Orthopaedics, University of Utah School of Medicine. "Because these implants have a combination of distinguishing features, I would expect Amedica's implants to be well received in Europe and Asia, where allograft bone is not frequently used."

"Obtaining the CE mark for our Valeo ceramic spinal spacers expands our ability to bring our portfolio of innovative spinal implant products to important markets in Europe, Asia and other regions of the world," said Ashok Khandkar, Ph.D., Chief Executive Officer of Amedica Corporation. "This achievement gives us the ability to begin to educate and train physicians in Europe and other foreign markets so that more patients can benefit from our innovative implants."

About Amedica

Amedica Corporation is an emerging orthopedic implant company focused on using its silicon nitride ceramic technologies to develop and commercialize a broad range of innovative, high-performance spine and joint implants for the growing orthopedic device market. Its products under development include spine, reconstructive hip and knee implants that may represent a new standard of care in total joint implants based on superior durability, performance and safety.

Amedica Corporation
http://www.amedicacorp.com