AxioMed Spine Corporation Initiates Pivotal Study

Main Category: Neurology / Neuroscience
Also Included In: Bones / Orthopedics;  Medical Devices / Diagnostics;  Rehabilitation / Physical Therapy
Article Date: 01 Oct 2008 - 5:00 PDT

email to a friend   printer friendly   opinions  

AxioMed® Spine Corporation, focused on next-generation devices for the restoration of spinal function, announces the initiation of its pivotal clinical study of the Freedom® Lumbar Disc, an elastomeric total disc replacement device. This multi-center pivotal trial in the US and EU follows Food and Drug Administration (FDA) approval of the company's Investigational Device Exemption (IDE) application and successful completion of enrollment for AxioMed's multi-center pilot clinical study in the EU.

Patrick McBrayer, AxioMed's President and CEO stated, "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."

Neal Defibaugh, AxioMed's Vice President of Clinical and Regulatory Affairs, added, "AxioMed has designed our pivotal clinical study with input from patients, surgeons, third party payers and reimbursement experts. We intend to provide clinical and economic outcome information so that appropriate decisions can be made by surgeons and third party payers for the surgical use of our Freedom Lumbar Disc."

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. The Company's 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.

About AxioMed Spine Corporation

AxioMed's mission is to develop products focused on spinal function for patients with degenerative spine disease, thus advancing the standard of care beyond fusion and first generation discs. The Freedom Lumbar Disc was developed and designed by a team of clinicians and experts in the fields of biomechanics, pathology, spinal surgery and polymer science. Focusing on restoration of the natural function of the spine, AxioMed will enhance human health through research, innovation, development and service world-wide.

AxioMed Spine Corporation

• Additional
• References
• Citations