The Bryan cervical disc system

被引：11
|
作者：
Papadopoulos, S [1 ]
机构：
[1] Barrow Neurol Inst, Phoenix, AZ 85013 USA
来源：
NEUROSURGERY CLINICS OF NORTH AMERICA | 2005年 / 16卷 / 04期
关键词：
D O I：
10.1016/j.nec.2005.06.003
中图分类号：
R74 [神经病学与精神病学];
学科分类号：
摘要：
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.
引用
收藏
页码：629 / +
页数：9
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