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

Overview

Journal Acta Cardiol Sin

Date 2020 Nov 25

PMID 33235423

Citations 2

Authors

Wei Cai

En Chen

Xiaoling Zeng

Canqiang Chen

Lingzhen Wu

Xingchun Zheng

Lianglong Chen

Affiliations

Soon will be listed here.

Abstract

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.

Citing Articles

Mid-Term Outcomes of Novel Covered Stent with Biodegradable Membrane in Porcine Coronary Artery Perforation.

Cai W, Chen E, Zheng H, Hu D, Wu L, Zeng X Rev Cardiovasc Med. 2024; 24(7):197.

PMID: 39077012 PMC: 11266466. DOI: 10.31083/j.rcm2407197.

The Best Strategy for the Black Hole Phenomenon between Intravascular Ultrasound and Optical Coherence Tomography.

Kan C, Tsai W, Cheng C, Jong G Diagnostics (Basel). 2024; 14(3).

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