Device profile of the sapphire X < sup > TM < /sup > anterior cervical plate system: overview of its safety and efficacy

Expert Rev Med Devices. 2021 Sep 1:1-6. doi: 10.1080/17434440.2021.1971970. Online ahead of print.ABSTRACTIntroduction:The Sapphire X Anterior Cervical Plate System is a new medical device designed to provide stability after anterior discectomy and fusion procedures. It has unique benefits over many of the more established plates on the market. It is manufactured predominantly from titanium alloy and was first launched in late 2020.Areas covered:The structure and unique features of the Sapphire X are described. The indications for its use are discussed. The delivery system designed for the plate is reviewed in detail. Research outlining the shortcomings of current plate technologies and alternative technologies in this market space are reviewed.Expert Opinion:The evidence in this article demonstrates the risk of adjacent-level ossification development (ALOD) with current cervical plate designs. The industry is saturated with cervical plate technologies, yet there are very few plates small enough to avoid encroaching upon adjacent levels of disc space, particularly in the upper subaxial cervical segments and in patients with small vertebrae. This device review demonstrates the successful application of a cervical plate device that is small enough to avoid encroachment on the adjacent-level disc spaces while providing immediate stability after discectomy and fusion in the cervical spine.PMID:34432546 | DOI:10.1080/17434440.2021.1971970
Source: Expert Review of Medical Devices - Category: Medical Devices Authors: Source Type: research