Device profile of the Mobi-C artificial cervical disc: an overview of its safety and efficacy.

IF 2.7
Expert review of medical devices Pub Date : 2025-01-01 Epub Date: 2025-01-06 DOI:10.1080/17434440.2024.2449504
Kee D Kim, Katherine A Curran, Richard L Price, Safdar Khan
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Abstract

Introduction: The Mobi-C Cervical Disc Replacement is a motion preserving alternative to anterior cervical discectomy and fusion in properly indicated patients. In 2013, Mobi-C became the first cervical disc in the United States approved to treat more than one level of the cervical spine. The FDA determined Mobi-C to be statistically superior to fusion at two levels, based on the primary endpoint of a prospective, concurrently controlled and randomized multicenter clinical trial.

Areas covered: The history of Mobi-C and cervical disc arthroplasty is discussed. The unique biomechanics and structure of Mobi-C, the clinical results, the long term follow-up, the disc's biomechanics, and cost-effectiveness research are described. The competitive landscape is overviewed.

Expert opinion: The evidence in this article supports the use of the Mobi-C cervical disc prosthesis as a viable alternative to fusion surgery in selected patients. Mobi-C has a relatively long track record compared to most other cervical disc prostheses. Thus far, Mobi-C is a very good option for preserving cervical motion based on long term follow-up, for achieving favorable clinical outcomes, and for maintaining patient safety. The Mobi-C cervical disc prosthesis is generally viewed positively, supported by clinical experience and research findings.

Mobi-C人工颈椎间盘的器械概况:安全性和有效性综述
Mobi-C颈椎椎间盘置换术是一种保留运动的方法,可以替代前路颈椎椎间盘切除术和融合术。2013年,Mobi-C成为美国第一个被批准用于治疗多个颈椎节段的颈椎间盘。基于一项前瞻性、同时对照和随机多中心临床试验的主要终点,FDA确定Mobi-C在统计学上优于2个水平的融合。涵盖领域:讨论了Mobi-C和颈椎间盘置换术的历史。本文描述了Mobi-C独特的生物力学和结构、临床结果、长期随访、椎间盘的生物力学和成本效益研究。本文概述了竞争格局。专家意见:本文的证据支持在选定的患者中使用Mobi-C颈椎间盘假体作为融合手术的可行替代方案。与大多数其他颈椎间盘假体相比,Mobi-C具有相对较长的记录。迄今为止,Mobi-C是一种非常好的选择,可以在长期随访的基础上保持颈椎运动,获得良好的临床结果,并维护患者的安全。在临床经验和研究结果的支持下,人们对Mobi-C颈椎间盘假体普遍持积极态度。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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