AxioMed Spine Corp. has announced it has received the CE mark approval for its Freedom cervical disc, according to a news release.
The mark clears AxioMed for the introduction of Freedom, an elastomeric total spinal disc replacement device, into the European Union market. AxioMed describes the product as a "viscoelastic one-piece, next generation total disc replacement featuring a polymer core, designed with the goal of restoring function of the spine and reducing pain and disability."AxioMed previously received a CE mark for its Freedom lumbar disc in 2009.
"With the Freedom lumbar and cervical discs now both CE marked, we will be able to provide a complete next generation elastomeric disc product line for patients and surgeons in the European Union," said Patrick McBrayer, AxioMed's president and CEO, in the release. "Our European Union lumbar clinical data, published in peer reviewed spine journals, demonstrate that Freedom technology has been shown to provide patients pain relief, reduced disability and improved lifestyle, based on monitored outcomes and feedback. We are also active in our multi-center pivotal clinical study under an Investigational Device Exemption for our Freedom lumbar disc with both efficacy and economic endpoints. Our goal is to have the most advanced and complete total disc product line in the United States and European Union."
AxioMed is headquartered in Garfield Heights, Ohio.
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