In vivo biological safety evaluation of an iron-based bioresorbable drug-eluting stent
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In vivo biological safety evaluation of an iron-based bioresorbable drug-eluting stent Jianfeng Shi . Xuewen Miao . Haiyang Fu . Aili Jiang . YanFen Liu . XiaoLi Shi . Deyuan Zhang . Zhaoxu Wang
Received: 2 February 2020 / Accepted: 29 August 2020 Springer Nature B.V. 2020
Abstract Bioresorbable stents (BRS) are investigated and designed to revascularize occluded arteries. The iron-based bioresorbable stent is a promising device in interventional therapies, although it’s corrosion and bioresorption rate remain challenging. In this work, we introduced a novel nitrided iron coronary stent (IBS) with enhanced degradation rate compared with pure iron stent. To evaluate the biosafety of this device, a sub-chronic systemic Jianfeng Shi, Xuewen Miao have contributed equally to this work. Deyuan Zhang and Zhaoxu Wang are the co-corresponding authors.
Electronic supplementary material The online version of this article (https://doi.org/10.1007/s10534-020-00244-2) contains supplementary material, which is available to authorized users. J. Shi H. Fu Z. Wang (&) Testing Department of Biomaterials, Chinese National Institutes for Food and Drug Control, Beijing 102629, China e-mail: [email protected] X. Miao A. Jiang College of Life Science, YanTai University, YanTai 264005, China Y. Liu X. Shi D. Zhang (&) R&D Center, Lifetech Scientific (Shenzhen) Co Ltd, Shenzhen 518057, China e-mail: [email protected]
toxicity study was conducted and a stainless steel stent (SupporterTM) served as a control. Here, the bioresorbable stent was first evaluated in rat abdominal aortic implantation model. When subjected to exaggerated exposure dose, no clinical signs of toxicity or mortality were observed in either, the IBS group or the control group. Histopathological examinations showed the corrosion particles of iron were encapsulated by fibrocytes and engulfed by macrophages, indicating that the degradation of iron was in the early stage. Our results demonstrated that the nitrided iron stent did not induce systemic toxicity under the experimental conditions. Keywords Bioresorbable iron-based stent Biosafety Sub-systemic toxicity evaluation
Introduction Bioresorbable stents (BRS) were heralded as the ‘fourth revolution’ in interventional cardiology, which were designed to avoid the long term health risks posed by drug eluting stents (DES), i.e. late stent thrombosis, inflammatory reaction and neoatherosclerotic lesion (Daemen et al. 2007; Farb et al. 2002; Serruys et al. 2010). The ideal BRS should be completely degraded after providing a temporary radial support to preclude recoil and allow
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vascular restoration. Its degradation rate should adapt to the arterial vessel remodeling procedure and materials used should have good biocompatibility to prevent vessel irritation. The promising potential of BRS lead to technological drive of stent manufacturing industry. Biodegradable polymers and metals have been used to manufacture BRS. To date, the devel
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