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

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. ＜br＞ Objective: The aim of this study was to evaluate the biosafety and efficacy of Firesorb-C in rabbits. ＜br＞ 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. ＜br＞ 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