The AxioMed Spine Corporation, of Garfield Heights, Ohio, has introduced its Freedom Cervical Disc in Europe and successful implanted its first such device in Switzerland. The firm, which received the CA Mark for it in 2012, developed the total disc replacement device for the treatment of cervical degenerative disc disease.
AxioMed’s Chief Operating Officer Jim Kuras described the disc, saying, “The Freedom Cervical Disc’s unique asymmetrical design and resulting biomechanics represent advancement beyond the first generation total disc technologies, and better accommodates the cervical anatomy and spinal function. The differentiated design, with multiple footprints and heights combined with a wedge angle, provide the surgeon with an array of implants to address patient specific surgical requirements.”
He continued, “The Freedom Lumbar and Cervical Disc technology is a second generation, viscoelastic polymer one-piece spinal disc replacement prosthesis that provides a combination of stability, compressibility and controlled motion that closely replicates the natural function of the native disc. The surgical procedure requires a limited number of instruments, is simple and reproducible, and requires no bone-milling or excess sculpting of the intervertebral body endplates to implant the device.”
Neal Defibaugh, AxioMed’s vice president of clinical and regulatory affairs said: “AxioMed is committed to conduct a Freedom Cervical Disc study in Europe that supports our goal of post-market surveillance. The clinical study will provide additional data that complements the current, extensive biomechanical and biocompatibility test data that has been completed for the Freedom Cervical Disc.”
The study’s clinical results will be used to support a future Investigational Device Exemption (IDE) application to the U.S. FDA and to support regulatory approval in other markets outside of the EU.
