The Bryan cervical disc system.
In May 2002, an Investigational Device Exemption (IDE) was granted by the US Food and Drug Administration (FDA) for clinical evaluation of the Bryan Cervical Disc System. The trial was designed to demonstrate equivalence with anterior discectomy and interbody fusion with plate fixation. Trial enrollment of over 500 patients was completed in 2004, and 2-year follow-up data are currently being collected and analyzed in preparation for submission to the FDA. This article describes the Bryan prosthesis, reviews several preclinical and clinical studies, and reports on the IDE study.
Papadopoulos
Stephen
S
Barrow Neurological Institute, Phoenix, AZ 85013, USA. stvpapa@bnaneuro.net
D000818:Animals; D019643:Arthroplasty, Replacement; D002574:Cervical Vertebrae / Q000601:surgery*; D018795:Device Approval; D006801:Humans; D007403:Intervertebral Disc / Q000601:surgery*; D007405:Intervertebral Disc Displacement / Q000601:surgery*; D007595:Joint Prosthesis; D011474:Prosthesis Design; D013128:Spinal Osteophytosis / Q000601:surgery*; D014481:United States