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LithoVue 一次性使用数字软性输尿管镜在肾结石取石术中的器械特征:安全性和疗效概述。

Device profile of the LithoVue single-use digital flexible ureteroscope in the removal of kidney stones: overview of safety and efficacy.

机构信息

Department of Urologic Sciences, University of British Columbia , Vancouver, Canada.

Department of Urology, Vanderbilt University Medical Center , Nashville, TN, USA.

出版信息

Expert Rev Med Devices. 2020 Dec;17(12):1257-1264. doi: 10.1080/17434440.2020.1848538. Epub 2020 Dec 14.

Abstract

: Flexible ureteroscopy is a commonly performed urologic procedure for visualization and treatment of the upper urinary tracts. Traditionally, ureteroscopy has been performed with reusable scopes, which have large initial purchasing costs. LithoVue was the first widely adopted single-use flexible ureteroscope clinically available in 2016 and has caused reevaluation of this paradigm. : This review is an objective assessment of the LithoVue single-use ureteroscope based on available studies at the time of publication. The authors searched major databases for papers that included the term 'LithoVue' and included relevant papers. The state of the market, technical specifications, results from clinical studies and cost analyses, and competitors are discussed. : The LithoVue single-use flexible ureteroscope has comparable clinical performance to existing reusable ureteroscopes based on available data. Direct clinical comparisons to competing single-use ureteroscopes, many of which are relatively new, are limited. In numerous pre-clinical studies LithoVue performed favorably compared to available competitors. Cost analyses suggest that benefit of single-use ureteroscopes is institution-specific, and will likely be favorable at a low volume of cases and with high local costs for repairs of reusable scopes.

摘要

软性输尿管镜检查是一种常用于上尿路可视化和治疗的泌尿科操作。传统上,输尿管镜检查使用可重复使用的内窥镜进行,这些内窥镜的初始购买成本较高。LithoVue 是 2016 年第一个被广泛采用的临床应用的一次性使用软性输尿管镜,并重新评估了这一模式。

本综述基于发表时可获得的研究,对 LithoVue 一次性使用输尿管镜进行了客观评估。作者在主要数据库中搜索了包含“LithoVue”一词的论文,并纳入了相关论文。讨论了市场状况、技术规格、临床研究和成本分析结果以及竞争对手。

基于现有数据,LithoVue 一次性使用软性输尿管镜的临床性能与现有的可重复使用输尿管镜相当。与竞争的一次性使用输尿管镜的直接临床比较有限,其中许多是相对较新的。在许多临床前研究中,与现有竞争对手相比,LithoVue 的表现更优。成本分析表明,一次性使用输尿管镜的优势是特定于机构的,并且在低病例量和可重复使用内窥镜维修成本较高的情况下可能是有利的。

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