AxioMed Spine has received CE mark approval for its Freedom Cervical Disc, an elastomeric total spinal disc replacement device.
Patrick McBrayer, president and CEO, AxioMed said: “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 EU. Our EU 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 multicentre 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 USA and EU.”
Jim Kuras, chief operating officer, AxioMed said: “The Freedom Cervical Disc was developed by an experienced team of surgeons and engineers, taking advantage of the attributes of the lumbar technology and advancing the technology platform into the cervical spine. The cervical disc’s unique asymmetrical design and biomechanics evolve beyond first generation total disc technologies, better accommodating 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.”
AxioMed’s first product was the Freedom Lumbar Disc which received CE Mark in 2009.