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AxioMed Research

Investigational Device Exemption (IDE) Lumbar Clinical Trial 

Freedom Lumbar Disc (FLD) One-Level IDE Pivotal Study in the Treatment of Lumbar Degenerative Disc Disease completed in 2015

The Freedom Lumbar Disc is indicated for spinal arthroplasty in skeletally mature patients with single level, symptomatic degenerative disc disease (DDD) from L3-S1. This was a prospective, multi-center, randomized, controlled trial. 300 patients with DDD was randomized to disc arthroplasty with the FLD device or the ProDisc (control device). The overall purpose (objective) of this trial was to collect clinical data to demonstrate the safety and effectiveness of FLD used for the treatment of symptomatic lumbar degenerative disc disease compared to the control device.

AxioMed Studies

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Kingsley R. Chin^, Jacob Ryan Lubinski, Kari Bracher Zimmers, Barry Eugene Sands, Fabio Pencle

The Freedom Cervical Disc (FCD) performs as expected in patients with single-level and two-level degenerative disc disease.  In this early clinical experience with the FCD, patients experienced similar pain relief and lower disability at 2 years follow-up compared to both articulating and viscoelastic TDRs

Preclinical and clinical experience with a viscoelastic total disc replacement (VTDR)

Burkhard Rischke, MD, PhD, Raymond S. Ross, MD, Boris A. Jollenbeck, MD,  Kari B. Zimmers, BS*, Neal D. Defibaugh, BS

The VTDR is intended to restore healthy anatomic properties and stability characteristics to the spinal segment.  This  study is the first to evaluate a VTDR in a 50-patient, multicenter European study

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The development of “second-generation” viscoelastic implants offers new possibilities to better restore the disc function by providing damping capacity, flexural stiffness and coupled movements at the implanted level.

Significantly higher back and leg pain relief were observed after viscoelastic total disc replacement in comparison with anterior lumbar interbody fusion.

Mechanical Characterization of a Viscoelastic Disc for Lumbar Total Disc Replacement

Edward C. Benzel, Isador H. Lieberman, E. Raymond Ross, Raymond J. Linovitz, James Kuras, Kari Zimmers

The one-piece VTDR evaluated in this biomechanical study, replicating the ROM, flexibility, and stiffness of a natural lumbar disc, represents the next-generation lumbar TDR and promises over 50 years of durability.

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