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 toxicity study was conducted and a stainless steel stent (Supporter™) 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.

生物可吸收支架 (BRS) 被研究和设计用于使闭塞的动脉血运重建。铁基生物可吸收支架是介入治疗中一种很有前途的装置，尽管它的腐蚀和生物再吸收率仍然具有挑战性。在这项工作中，我们介绍了一种新型氮化铁冠状动脉支架 (IBS)，与纯铁支架相比，其降解率更高。为了评估该装置的生物安全性，进行了亚慢性全身毒性研究，并以不锈钢支架 (Supporter™) 作为对照。在这里，生物可吸收支架首先在大鼠腹主动脉植入模型中进行了评估。当受到夸大的暴露剂量时，在 IBS 组或对照组中均未观察到毒性或死亡的临床迹象。组织病理学检查显示铁的腐蚀颗粒被纤维细胞包裹并被巨噬细胞吞噬，表明铁的降解处于早期阶段。我们的结果表明，氮化铁支架在实验条件下不会引起全身毒性。