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Published on: August 28, 2014
In vitro and in silico testing of partially and fully bioresorbable vascular scaffold
Nenad Filipovic1, Dalibor Nikolic1, Velibor Isailovic1
1Bioengineering Research and Development Center, BioIRC, Kragujevac, Serbia; Faculty of Engineering, University of Kragujevac, Serbia.
Insights
In vitro and in silico testing of bioresorbable vascular scaffolds (BVS) showed strong correlations. This study suggests in silico methods can replace some mechanical testing for coronary stent regulatory submissions.
Area of Science:
- Biomedical Engineering
- Materials Science
- Medical Devices
Background:
- Coronary artery disease (CAD) is a leading global cause of death, often treated with percutaneous transluminal coronary angioplasty (PTCA).
- PTCA involves balloon angioplasty and coronary stent deployment to open blocked arteries and restore blood flow.
- Bioresorbable vascular scaffolds (BVS) are advanced devices used in CAD treatment, requiring rigorous mechanical testing.
Purpose of the Study:
- To evaluate the in vitro and in silico mechanical performance of bioresorbable vascular scaffolds (BVS).
- To compare the accuracy of in silico simulations against standard in vitro mechanical testing methods for coronary stents.
- To assess the potential of in silico testing to streamline regulatory submissions for BVS.
Main Methods:
- Development of a material model for poly-L-lactic acid (PLLA) for use in in-house simulation software.
- Conducting in vitro mechanical tests (inflation, radial compression, crush resistance) on BVS.
- Performing in silico simulations of the same mechanical tests and comparing results with experimental data.
Main Results:
- A strong correlation (R² > 0.99, R > 0.99) was observed between in silico simulation results and in vitro experimental data.
- The study demonstrated that in silico tests can effectively mimic established ISO standards for mechanical in vitro stent testing.
- Graphs comparing displacement-force, diameter-load, and diameter-pressure curves showed high agreement between simulated and real-world outcomes.
Conclusions:
- In silico testing provides a reliable method for evaluating the mechanical properties of coronary stents and BVS.
- Computational modeling can significantly reduce the need for extensive physical mechanical testing in BVS development.
- This approach offers a pathway to partially or fully replace mechanical testing for regulatory submissions, accelerating device approval.
Abstract:
Coronary artery disease (CAD), one of the leading causes of death globally, occurs due to the growth of atherosclerotic plaques in the coronary arteries, causing lesions which restrict the flow of blood to the myocardium. Percutaneous transluminal coronary angioplasty (PTCA), including balloon angioplasty and coronary stent deployment is a standard clinical invasive treatment for CAD. Coronary stents are delivered using a balloon catheter inserted across the lesion. The balloon is inflated to a nominal pressure, opening the occluded artery, deploying the stent and improving the flow of blood to the myocardium. All stent manufacturers have to perform standard in vitro mechanical testing under different physiological conditions. In this study, partially and fully bioresorbable vascular scaffolds (BVS) from Boston Scientific Limited have been examined in vitro and in silico for three different test methods: inflation, radial compression and crush resistance. We formulated a material model for poly-L-lactic acid (PLLA) and implemented it into our in-house software tool. A comparison of the different experimental results is presented in the form of graphs showing displacement-force curves, diameter - load curves or diameter - pressure curves. There is a strong correlation between simulation and real experiments with a coefficient of determination (R2) > 0.99 and a correlation coefficient (R) > 0.99. This preliminary study has shown that in-silico tests can mimic the applicable ISO standards for mechanical in vitro stent testing, providing the opportunity to use data generated using in-silico testing to partially or fully replacing the mechanical testing required for regulatory submission.
