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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 Publications
02
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
03
JBJS Am . 2025 Nov 24
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
04
J Spine Surg. 2017 Dec;3(4).
Kingsley R. Chin^, Jacob Ryan Lubinski, Kari Bracher Zimmers, Barry Eugene Sands, Fabio Pencle
07
SAS J . 2010 Mar 1;4(1)
Clinical performance of an elastomeric lumbar disc replacement: Minimum 12 months follow-up
Luiz Pimenta, Raul Springmuller, Casey K Lee, Leonardo Oliveira, Sandra E Roth, William F Ogilvie
10
Global Spine J. 2018 Jun;8(4)
Jack Zigler, Matthew F Gornet, Nicole Ferko, Chris Cameron, Francine W Schranck, Leena Patel
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
Luiz Pimenta^, Leonardo Oliveira, Thomas Schaffa, Etevaldo Coutinho, Luis Marchi
Gabriel Pokorny^, Luís Marchi, Rodrigo Amaral, Rubens Jensen, Luiz Pimenta
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