AxioMed Spine has received CE mark approval for its elastomeric total spinal disc replacement device, Freedom Cervical Disc.
The Freedom Cervical Disc features a polymer core designed to restore spine function and reduce pain and disability.
AxioMed Spine chief operating officer Jim Kuras said thee cervical disc’s asymmetrical design and biomechanics evolve beyond first generation total disc technologies and better accommodate the cervical anatomy and spinal function.
"Complementing the differentiated design, multiple footprints and heights with wedge angles provide the surgeon with an array of implants to address the patient specific surgical requirements," Kuras added.
The company has also received CE mark approval for its Freedom Lumbar Disc in 2009.
AxioMed president and CEO Patrick McBrayer said the company is also active in its multi-center pivotal clinical study under an Investigational Device Exemption for its Freedom Lumbar Disc with both efficacy and economic endpoints.