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news.AxioMed Spine, a developer of next-generation devices for the restoration of spinal function, has initiated its pivotal clinical study of the Freedom Lumbar Disc, an elastomeric total disc replacement device.
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The company said that the pivotal study is a multi-center US and EU evaluation of the Freedom Lumbar Disc in skeletally mature patients with single-level degenerative disc disease and is designed with efficacy and safety as well as economic endpoints.
This multi-center pivotal trial in the US and EU follows FDA approval of the company’s investigational device exemption application and successful completion of enrollment for AxioMed’s multi-center pilot clinical study in the EU.
According to the company, the Freedom Lumbar Disc is a viscoelastic one-piece, next-generation total disc replacement, featuring a polymer core and was designed with the goal of restoring the natural function of the spine, thereby reducing pain and disability.
Patrick McBrayer, AxioMed’s president and CEO, said: “The Freedom Lumbar Disc is the only elastomeric total disc replacement device to complete a rigorous multi-center pilot study in the EU and enter a pivotal clinical study.
“We are particularly pleased with the positive reception from potential surgeon investigators who are seeking a technology that restores the natural function of the disc, thus providing patients pain relief, mobility and a healthier lifestyle.”