endoanchor用于主动脉支架植入术的设备概况:其安全性和有效性综述。

IF 2.9 3区医学 Q3 ENGINEERING, BIOMEDICAL

Expert Review of Medical Devices Pub Date : 2023-07-01 DOI:10.1080/17434440.2023.2221787

Daniel Curley, Jan Sindhar, Adam Howard, Hany Zayed, Prakash Saha

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引用次数: 0

摘要

血管内动脉瘤修复(EVAR)和胸椎血管内动脉瘤修复(TEVAR)是治疗腹主动脉瘤(AAA)和胸主动脉瘤(TAA)的成熟技术。然而，当具有挑战性的近端颈部解剖存在局限性。除了EVAR和TEVAR外，Heli-FX endoanchor也被用于改善支架移植物近端密封，但关于其结果、安全性和有效性的数据有限。涉及领域:对Heli-FX endoanchor的性能和发展进行了评估。随着Heli-FX EndoAnchors与EVAR或TEVAR的广泛使用，各种临床结果、安全性和有效性的证据受到质疑。专家意见:在EVAR或TEVAR中，具有挑战性的近端颈部解剖可能会出现问题。内锚可能是解决方案的一部分-用于预防或治疗。安全性和有效性数据库正在建立，但该设备的长期数据仍然不可用，并且仍然没有足够的数据来支持其常规使用。仍然需要明智地选择病人。

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Device profile of EndoAnchors for aortic stent graft implantation: overview of their safety and efficacy.

Introduction: Endovascular aneurysm repair (EVAR) and thoracic endovascular aneurysm repair (TEVAR) are established techniques to treat abdominal aortic aneurysms (AAA) and thoracic aortic aneurysms (TAA). However, there are limitations when challenging proximal neck anatomy is present. Heli-FX EndoAnchors have been used in addition to EVAR and TEVAR to improve proximal sealing of a stent-graft, but there are limited data available on their outcomes, safety, and efficacy.

Areas covered: The properties and development of Heli-FX EndoAnchors are evaluated. The evidence of various clinical outcomes, safety, and efficacy is interrogated with the augmented use of Heli-FX EndoAnchors with EVAR or TEVAR.

Expert opinion: Challenging proximal neck anatomy can be problematic during EVAR or TEVAR. EndoAnchors may be part of the solution - used either prophylactically or therapeutically. The safety and efficacy databases are building but long-term data are still not available for this device and there remains inadequate data to support its routine use. Judicious patient selection is still needed.

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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.