Peregrine system infusion catheter for neurolytic renal denervation in hypertension: an overview of its safety and efficacy.

IF 2.9 3区 医学 Q3 ENGINEERING, BIOMEDICAL Expert Review of Medical Devices Pub Date : 2023-03-01 DOI:10.1080/17434440.2023.2183838
Adam Janas, Wojciech Wojakowski
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Abstract

Introduction: Resistant hypertension (HTN), despite the tremendous advances in pharmacotherapy, is a major global problem. Transcatheter renal denervation (RDN) could be a pertinent strategy for resistant HTN and patients with poor pharmacotherapy adherence. Nonetheless, the adoption of energy-based RDN in clinical practice is slow and alternative approaches are needed.

Areas covered: The review focuses on the assessment of the Peregrine System Infusion Catheters. The system is designed for chemically mediated transcatheter RDN by the infusion publications on the Peregrine system. The theoretical assumptions for chemically mediated RDN, design of the system, data from preclinical and clinical studies, and further perspectives are discussed.

Expert opinion: Peregrine System Infusion Catheters are the only catheter on the market designed for chemically mediated RDN by the infusion of the neurolytic agent. Chemical neurolysis more efficiently destroys nerves around the renal artery in comparison to energy-based catheters, due to deeper tissue penetration and circumferential distribution resulting in a wider range of effective nerve injury. Chemically mediated RDN by the infusion of the neurolytic agent (alcohol) has an excellent safety profile as confirmed in initial clinical trials which also suggested high efficacy. Currently, there is an ongoing phase III sham-control study. Other possible applications of this technology include clinical settings like heart failure or atrial fibrillation.

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游隼系统输注导管用于高血压神经溶解性肾去神经:其安全性和有效性综述。
导言:尽管药物治疗取得了巨大进步,但顽固性高血压(HTN)仍是一个重大的全球性问题。经导管肾去神经(RDN)可能是耐药HTN和药物治疗依从性差的患者的相关策略。然而,在临床实践中采用基于能量的RDN是缓慢的,需要替代方法。涉及领域:综述的重点是对游隼系统输液管的评估。该系统是通过Peregrine系统上的输液出版物设计的化学介导的经导管RDN。讨论了化学介导RDN的理论假设、系统设计、临床前和临床研究的数据以及进一步的观点。专家意见:Peregrine系统输注导管是市场上唯一设计用于通过输注神经溶解剂化学介导的RDN的导管。与能量导尿管相比,化学神经松解术能更有效地破坏肾动脉周围的神经,这是因为化学神经松解术能穿透更深的组织,并能形成更大范围的有效神经损伤。通过输注神经溶解剂(酒精)化学介导的RDN具有极好的安全性,初步临床试验证实了这一点,这也表明了很高的疗效。目前,有一项正在进行的III期假对照研究。这项技术的其他可能应用包括临床设置,如心力衰竭或心房颤动。
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来源期刊
Expert Review of Medical Devices
Expert Review of Medical Devices 医学-工程:生物医学
CiteScore
5.90
自引率
3.20%
发文量
69
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.
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