AxioMed Spine wins CE Mark for Freedom lumbar disc

AxioMed Spine has received CE Mark approval for its Freedom lumbar disc, an elastomeric total spinal disc replacement device.

The CE Mark approval was received from the notified body after review of the company’s multi-center European clinical study and its portfolio of biocompatibility and biomechanical testing. This data also supported AxioMed’s investigational device exemption approval by the FDA. The CE Mark clears AxioMed for the introduction of the Freedom lumbar disc into the EU market.

According to AxioMed Spine, the Freedom lumbar disc is 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 said that its pivotal study, a multi-center US and EU evaluation of the Freedom lumbar disc in skeletally mature patients with single-level degenerative disc disease, is designed with efficacy, safety and economic endpoints.

Patrick McBrayer, president and CEO of AxioMed, said: The Freedom lumbar disc is the only elastomeric lumbar total disc replacement device to receive CE Mark approval based on a rigorous multi-center clinical study conducted in the EU. We are particularly pleased to be able to provide surgeons in Europe with the Freedom technology that has been shown to provide patients pain relief, reduced disability and improved lifestyle, based on monitored outcomes and feedback.