Department of Biomedical Engineering, Michigan Technological University, United States; Department of Biomedical Engineering and Physiology, Mayo Clinic Graduate School of Biomedical Sciences, United States.
Department of Materials Science and Engineering, Michigan Technological University, United States.
Acta Biomater. 2021 Jun;127:1-23. doi: 10.1016/j.actbio.2021.03.058. Epub 2021 Apr 3.
Over the past two decades, significant advancements have been made regarding the material formulation, iterative design, and clinical translation of metallic bioresorbable stents. Currently, magnesium-based (Mg) stent devices have remained at the forefront of bioresorbable stent material development and use. Despite substantial advances, the process of developing novel absorbable stents and their clinical translation is time-consuming, expensive, and challenging. These challenges, coupled with the continuous refinement of alternative bioresorbable metallic bulk materials such as iron (Fe) and zinc (Zn), have intensified the search for an ideal absorbable metallic stent material. Here, we discuss the most recent pre-clinical and clinical evidence for the efficacy of bioresorbable metallic stents and material candidates. From this perspective, strategies to improve the clinical performance of bioresorbable metallic stents are considered and critically discussed, spanning material alloy development, surface manipulations, material processing techniques, and preclinical/biological testing considerations. STATEMENT OF SIGNIFICANCE: Recent efforts in using Mg, Fe, and Zn based materials for bioresorbable stents include elemental profile changes as well as surface modifications to improve each of the three classes of materials. Although a variety of alloys for absorbable metallic stents have been developed, the ideal absorbable stent material has not yet been discovered. This review focuses on the state of the art for bioresorbable metallic stent development. It covers the three bulk materials used for degradable stents (Mg, Fe, and Zn), and discusses their advances from a translational perspective. Strategies to improve the clinical performance of bioresorbable metallic stents are considered and critically discussed, spanning material alloy development, surface manipulations, material processing techniques, and preclinical/biological testing considerations.
在过去的二十年中，在金属生物可吸收支架的材料配方、迭代设计和临床转化方面取得了重大进展。目前，基于镁（Mg）的支架器械一直处于生物可吸收支架材料开发和应用的前沿。尽管取得了重大进展，但开发新型可吸收支架及其临床转化的过程既耗时、昂贵又具有挑战性。这些挑战，加上替代生物可吸收金属整体材料（如铁（Fe）和锌（Zn））的不断改进，加剧了对理想可吸收金属支架材料的探索。在这里，我们讨论了生物可吸收金属支架的最新临床前和临床疗效证据和候选材料。从这个角度来看，考虑并批判性地讨论了改善生物可吸收金属支架临床性能的策略，涵盖了材料合金开发、表面处理、材料加工技术以及临床前/生物学测试考虑因素。意义陈述：最近使用 Mg、Fe 和 Zn 基材料用于生物可吸收支架的努力包括元素轮廓变化以及表面改性，以改善这三类材料中的每一种。虽然已经开发了各种用于可吸收金属支架的合金，但尚未发现理想的可吸收支架材料。本综述重点介绍生物可吸收金属支架开发的最新技术。它涵盖了用于可降解支架的三种基体材料（Mg、Fe 和 Zn），并从转化的角度讨论了它们的进展。考虑并批判性地讨论了改善生物可吸收金属支架临床性能的策略，涵盖了材料合金开发、表面处理、材料加工技术以及临床前/生物学测试考虑因素。
