Expert review of medical devices · 2019
The Mobi-C® cervical disc and other devices for two-level disc replacement: overview of its safety and efficacy.
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Badve Siddharth A, Kurra Swamy, Nunley Pierce D, Lavelle William F
Аннотация
INTRODUCTION: Cervical disc arthroplasty (CDA) has become an acceptable alternative for anterior cervical discectomy and fusion (ACDF) for a significant patient population with cervical radiculopathy and/or myelopathy secondary to degenerative changes in the cervical spine. There are sufficient mid- and long-term data supporting performance and safety of one-level CDA. With the success of single-level cervical CDA, considerable interest exists about CDA use for multilevel cervical degenerative disc disease (DDD). This review analyzes the safety and efficacy of two-level CDA for treatment of symptomatic cervical DDD with focus on the Mobi-C® Cervical Disc.
AREAS COVERED: This review summarizes previously published articles in a literature search using keywords: 'two-level-anterior cervical arthrodesis; two-level anterior cervical decompression and fusion (ACDF); two-level cervical disc arthroplasty (CDA); two-level cervical total disc replacement; two-level symptomatic degenerative disc disease (DDD); Mobi-C® disc'.
EXPERT OPINION: Two-level CDA with the Mobi-C® device demonstrated equivalent, and in certain aspects, favorable outcomes compared to ACDF for treatment of symptomatic cervical 2-level degenerative disc disease (DDD) indicating a satisfactory safety and efficacy profile.
AREAS COVERED: This review summarizes previously published articles in a literature search using keywords: 'two-level-anterior cervical arthrodesis; two-level anterior cervical decompression and fusion (ACDF); two-level cervical disc arthroplasty (CDA); two-level cervical total disc replacement; two-level symptomatic degenerative disc disease (DDD); Mobi-C® disc'.
EXPERT OPINION: Two-level CDA with the Mobi-C® device demonstrated equivalent, and in certain aspects, favorable outcomes compared to ACDF for treatment of symptomatic cervical 2-level degenerative disc disease (DDD) indicating a satisfactory safety and efficacy profile.