Seven-year outcomes study data demonstrated statistical superiority of Zimmer Biomet’s Mobi-C® Cervical Disc Prosthesis vs. 2-level anterior cervical discectomy and fusion (ACDF) in overall success. The prospective, randomized, controlled trial was conducted as an FDA-regulated Investigational Device Exemption clinical trial.
Overall success required improvement in Neck Disability Index, no secondary surgical interventions at index levels and absence of major complications (e.g., radiographic failure, neurological failure or adverse events). Previous studies of Mobi-C include
Five-year results of Mobi-C cost utility analysis
Independent peer-reviewed 5-year follow-up: 2-level CDR vs. ACDF
No evidence of a reduction in efficacy with an increase from 1 to 2 treated levels
Mobi-C was the first cervical disc prosthesis approved by FDA for reconstruction of the cervical disc at both one and two levels. Medtronic’s Prestige LP cervical disc, for which 7-year data vs. ACDF is also available, received FDA approval for 2-level applications in 3Q16.
Seven-year outcomes study data demonstrated statistical superiority of Zimmer Biomet's Mobi-C® Cervical Disc Prosthesis vs. 2-level anterior cervical discectomy and fusion (ACDF) in overall success. The prospective, randomized, controlled trial was conducted as an FDA-regulated Investigational Device Exemption clinical trial.
Overall success...
Seven-year outcomes study data demonstrated statistical superiority of Zimmer Biomet’s Mobi-C® Cervical Disc Prosthesis vs. 2-level anterior cervical discectomy and fusion (ACDF) in overall success. The prospective, randomized, controlled trial was conducted as an FDA-regulated Investigational Device Exemption clinical trial.
Overall success required improvement in Neck Disability Index, no secondary surgical interventions at index levels and absence of major complications (e.g., radiographic failure, neurological failure or adverse events). Previous studies of Mobi-C include
Five-year results of Mobi-C cost utility analysis
Independent peer-reviewed 5-year follow-up: 2-level CDR vs. ACDF
No evidence of a reduction in efficacy with an increase from 1 to 2 treated levels
Mobi-C was the first cervical disc prosthesis approved by FDA for reconstruction of the cervical disc at both one and two levels. Medtronic’s Prestige LP cervical disc, for which 7-year data vs. ACDF is also available, received FDA approval for 2-level applications in 3Q16.
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