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[May 2009]
Amedica Receives CE Mark for Valeo™ Ceramic Spinal Implant System
Amedica Corporation (Salt Lake City, UT, USA), an orthopaedic implants company focused on silicon nitride ceramic technologies, has announced that it has received a CE (Conformité Européene) mark for initial rollout of its spinal intervertebral spacers using novel CSC (cancellous-structured ceramic) technology. The CSC technology, made using Amedica’s novel silicon nitride ceramic, offers a porous cancellous trabecular structure designed to promote bony fusion.
The Valeo family of ceramic spinal intervertebral spacers is intended to aid in surgical correction and stabilisation of the cervical and thoracolumbar spine. These implants are designed to restore the biomechanical integrity of the anterior, middle and posterior spine, 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 ceramic implants available for spinal use in the world.
“Amedica’s ceramic spinal spacers uniquely combine strength with improved ability for bony integration and bone-like imaging compatibility, making them a valuable alternative to currently available devices using conventional synthetic materials,” said Darrel Brodke MD, 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 CSC 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 Dr Ashok Khandkar, CEO of Amedica Corporation. “This achievement gives us the ability to begin to train physicians in Europe and other foreign markets so that more patients can benefit from our innovative implants.”
ENDS