AxioMed Spine Corporation
AxioMed Spine Corporation Initiates Pivotal Study
Published in Medical Letter on the CDC and FDA, October 19th, 2008
AxioMed(R) Spine Corporation (www.axiomed.com), focused on next-generation devices for the restoration of spinal function, announces the initiation of its pivotal clinical study of the Freedom(R) Lumbar Disc, an elastomeric total disc replacement device. This multi-center pivotal trial in the US and EU follows Food and Drug Administration (FDA) approval of the company's Investigational Device Exemption (IDE) application and successful completion of enrollment for AxioMed's multi-center pilot clinical study in the EU.
Patrick McBrayer, AxioMed's President and CEO stated, "The Freedom Lumbar Disc is the only elastomeric total disc replacement device to complete a rigorous...
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