Department of Cardiovascular Medicine, University Hospitals Leuven , Leuven , Belgium.
Department of Cardiology, CHU Saint-Pierre , Brussels , Belgium.
Expert Rev Med Devices. 2019 Sep;16(9):757-769. doi: 10.1080/17434440.2019.1649133. Epub 2019 Jul 30.
: Bioresorbable scaffold technology provides transient vessel support with drug-delivery capability without the long-term limitations of the permanent metallic drug-eluting stents (DES). The technology has the potential to overcome many of the safety concerns associated with metallic DES, such as hypersensitivity reactions, late stent thrombosis and progression of atherosclerosis within the stented segment (i.e. neoatherosclerosis). : The sirolimus-eluting resorbable magnesium scaffold Magmaris is the only metallic CE-marked resorbable scaffold currently available. This magnesium scaffold is designed for providing a short-term lumen support (up to 3 months) before being completely bioresorbed, eliminating the permanent caging typical of the metallic DES. This review will focus on the device development and characteristics, currently available clinical efficacy and safety data, and potential future perspectives. : The first clinical studies testing this device in a small number of patients have shown promising results with good clinical and safety outcomes up to 3 years' clinical follow-up, supporting the use of Magmaris in simple coronary artery disease.
生物可吸收支架技术提供了具有药物输送能力的临时血管支持，而没有永久性金属药物洗脱支架（DES）的长期局限性。该技术有可能克服与金属 DES 相关的许多安全问题，例如过敏反应、晚期支架血栓形成和支架段内动脉粥样硬化进展（即新生动脉粥样硬化）。西罗莫司洗脱可吸收镁支架 Magmaris 是目前唯一获得 CE 标志的金属可吸收支架。这种镁支架旨在提供短期的管腔支撑（长达 3 个月），然后完全被生物吸收，消除了金属 DES 典型的永久性笼状结构。本综述将重点介绍该设备的开发和特点、目前可用的临床疗效和安全性数据，以及潜在的未来前景。首批对该设备进行小样本患者测试的临床研究显示出有前景的结果，在长达 3 年的临床随访中，临床结果和安全性良好，支持 Magmaris 在简单冠状动脉疾病中的应用。
