Efficacy and Biosafety of a New Bioresorbable Vascular Scaffold Covered with Biodegradable Film in Rabbits: An In Vivo Study

• Published in: Acta Cardiologica Sinica 2020-11, Vol.36 (6), p.660-666
• Main Authors: Cai, Wei, Chen, En, Zeng, Xiaoling, Chen, Canqiang, Wu, Lingzhen, Zheng, Xingchun, Chen, Lianglong
• Format: Article
• Language: English
• Subjects: Basic Science; Original
• ISSN: 1011-6842
• DOI: 10.6515/ACS.202011_36(6).20200421B

Background: We developed a new fully bioresorbable vascular scaffold covered with biodegradable poly-L-lactic acid film (Firesorb-C) for coronary artery perforation. Our vitro tests have demonstrated that Firesorb-C was technically feasible but its biosafety and efficacy warranted further validation in vivo. Objective: The aim of this study was to evaluate the biosafety and efficacy of Firesorb-C in rabbits. Methods: Firesorb-C was deployed at the zone from the abdominal aorta to the right iliac artery in five rabbits. Angiography was conducted for evaluation of the immediate efficacy and 6-month biosafety and biodegradability of the Firesorb-C. Meanwhile, optical coherence tomography (OCT), histological light microscopy (HLM) and scan electron microscopy (SEM) were performed to evaluate the biosafety. Results: All Firesorb-C applications were successfully implanted without procedure-related complications. In all treated rabbits, angiography showed that the Firesorb-C had completely sealed the opening of the left iliac artery without blood flow in its branches but with full patency of the right iliac artery immediately post-procedurally, while the covered membrane of Firesorb-C had been degraded and blood flow was restored in the left iliac artery and its branches at 6months. OCT also found that the occluded left iliac artery had been reopened and the stented segment was almost fully endothelialized without in-stent restenosis at 6 months, meanwhile HLM and SEM confirmed comparable results. Conclusions: Firesorb-C is associated with excellent efficacy, biosafety and biodegradability in rabbits. It shows promise as a replacement for conventional covered stents for treatment of coronary artery perforation or for use in other clinical situations.