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AxioMed Research

Investigational Device Exemption (IDE) Lumbar Clinical Trial

Prospective, Multi-center, Randomized, Controlled IDE 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.


Research Abstracts
Pending Publication
AxioMed Studies
01
Clinical Biomechanics 130 (2025) 106686
ASTM biomechanical study comparing the AxioMed lumbar viscoelastic disc to human lumbar disc data
Kingsley R. Chin, Sukanya Chebrolu, Roger D. Sung, Jeffrey R. Carlson, Mark W. McFarland, Erik Spayde, William M. Costigan, Sandra Thompson, Vito Lore, Kari B. Zimmers, Hope Estevez, Swapnil Pangarkar, Aditya Humad, Chukwunonso C. Ilogua, Jason A. Seale
02
JBJS
Comparative in Vitro Analysis of Wear Particles Generated by a Viscoelastic Disc Versus 2 Articulating Total Disc Replacements
Kingsley R. Chin, Sukanya Chebrolu, Roger D. Sung, Jeffrey R. Carlson, Mark W. McFarland, Erik Spayde, William M. Costigan, Sandra Thompson, Vito Lore, Kari B. Zimmers, Hope Estevez, Swapnil Pangarkar, Aditya Humad, Chukwunonso C. Ilogua, Jason A. Seale
03
J Spine Surg. 2017 Dec;3(4).
Kingsley R. Chin^, Jacob Ryan Lubinski, Kari Bracher Zimmers, Barry Eugene Sands, Fabio Pencle

Lateral Viscoelastic Disc Studies

Dr. Kingsley R Chin (left) and Dr. Luiz Pimenta (right), inventor of the extreme lateral lumbar fusion (XLIF) approach for Nuvasive, at SMISS 2024










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