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. 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 6 months. 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.