Radial access for peripheral vascular intervention: the S.M.A.R.T. RADIANZ Vascular Stent System.

IF 2.9 3区医学 Q3 ENGINEERING, BIOMEDICAL Expert Review of Medical Devices Pub Date : 2023-07-01 Epub Date: 2023-07-24 DOI:10.1080/17434440.2023.2240227

Vinayak Subramanian, Antoine Sauguet, Martin Werner, Paolo Sbarzaglia, Klaus A Hausegger, Gilles Goyault, Mercedes Guerra, Koen Deloose, Andrea Kahlberg, Giovanni Balestriero, Marianne Brodmann, Christoph Binkert, Yann Goueffic, Gerd Groezinger, Arne Schwindt, Oliver Schlager, Luca Bertoglio, George Adams, Nusrath Sultana, Raphaël Coscas

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Abstract

Introduction: Radial access is the standard of care for nearly all cardiac catheterization procedures. It improves patient satisfaction, reduces the length of stay, and is associated with fewer complications. However, few devices and tools are available for the treatment of peripheral arterial disease via a transradial approach (TRA). The S.M.A.R.T. RADIANZ Vascular Stent System is among the RADIANZ suite of products, which is aimed at expanding the portfolio of devices to treat peripheral arterial disease.

Areas covered: In this Expert review, the following areas will be covered: (1) Current Landscape of peripheral vascular intervention (PVI) using TRA (2) Detailed description of the S.M.A.R.T. RADIANZ Vascular Stent System. (3) Ongoing clinical trials to evaluate safety of this approach. (4) Future directions and current regulatory status.

Expert opinion: TRA for PVI is a promising approach. It holds the possibility of substantially improving the care of patients with peripheral arterial disease (PAD). Numerous challenges must be overcome to realize the full potential of a radial-to-peripheral (RTP) approach. The length of devices and the small sheath size are the main constraints of this approach. The results of the ongoing RADIANCY trial will demonstrate the safety, in selected patients, of the RADIANZ suite of products.

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外周血管介入的桡动脉介入：S.M.A.R.T.RADIANZ血管支架系统。

引言：放射入路是几乎所有心导管插入术的标准护理。它提高了患者的满意度，缩短了住院时间，并减少了并发症。然而，很少有设备和工具可用于通过经桡动脉入路（TRA）治疗外周动脉疾病。S.M.A.R.T.RADIANZ血管支架系统是RADIANZ系列产品之一，旨在扩大治疗外周动脉疾病的设备组合。涵盖的领域：在本专家评审中，将涵盖以下领域：（1）使用TRA的外周血管介入（PVI）的现状（2）S.M.A.R.T.RADIANZ血管支架系统的详细描述。（3）正在进行的临床试验，以评估这种方法的安全性。（4）未来方向和当前监管状况。专家意见：PVI的TRA是一种很有前途的方法。它有可能大大改善外周动脉疾病（PAD）患者的护理。必须克服许多挑战才能充分发挥径向到外围（RTP）方法的潜力。器械的长度和较小的鞘管尺寸是这种方法的主要限制因素。正在进行的RADIANCY试验的结果将证明RADIANZ系列产品在选定患者中的安全性。

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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来源期刊

Expert Review of Medical Devices 医学-工程：生物医学

CiteScore

5.90

自引率

3.20%

发文量

审稿时长

6-12 weeks

期刊介绍： The journal serves the device research community by providing a comprehensive body of high-quality information from leading experts, all subject to rigorous peer review. The Expert Review format is specially structured to optimize the value of the information to reader. Comprehensive coverage by each author in a key area of research or clinical practice is augmented by the following sections: Expert commentary - a personal view on the most effective or promising strategies Five-year view - a clear perspective of future prospects within a realistic timescale Key issues - an executive summary cutting to the author''s most critical points In addition to the Review program, each issue also features Medical Device Profiles - objective assessments of specific devices in development or clinical use to help inform clinical practice. There are also Perspectives - overviews highlighting areas of current debate and controversy, together with reports from the conference scene and invited Editorials.