The Bryan Cervical Disc System

Department

neurosurgery

Document Type

Article

Abstract

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. © 2005 Elsevier Inc. All rights reserved.

Publication Date

2005

Publication Title

Neurosurgery Clinics of North America

ISSN

1042-3680

Volume

16

Issue

4

First Page

629

Last Page

636

Digital Object Identifier (DOI)

10.1016/j.nec.2005.06.003

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