Advancing BVS Design and Development through InSilc Platform

Bioresorbable Vascular Scaffolds (BVS) revolutionised the field of interventional cardiology by providing targeted drug delivery, mechanical support and complete resorption overcoming the barriers of bare-metal and drug-eluting stents. In vitro and in vivo experiments followed by clinical trials provide useful information on the safety and efficacy of BVS, however, these processes are time-consuming and raise ethical considerations. InSilc is an in silico clinical trial platform that accounts on the biological and biomedical knowledge and available advanced modelling approaches for simulating the short and medium/long term BVS performance. This is achieved by the integration of multidisciplinary and multiscale models that simulate the BVS mechanical behaviour, the deployment and degradation, the drug-delivery, the fluid dynamics and the myocardial perfusion. The integration of the models in the InSilc Cloud platform provides the final users (Stent Industry experts, Contract Research Organizations –CROs-, Interventional Cardiologists, Researchers) with fruitful information and assists in BVS improved design and development. The concept of InSilc involves the execution of computational simulations on “virtual” patients” given a “virtual” BVS, allowing for the evaluation of the scaffold performance, avoiding the adverse effects and undesirable clinical outcomes. The challenge of InSilc is two-fold: (i) validating the developed in silico models and addressing all the technological/cloud-based infrastructure requirements, (ii) creating a regulatory framework towards the successful application of InSilc in parallel with the real clinical trials. This work is supported by the InSilc project that has received funding from the European Union’s Horizon 2020 research and innovation program under grant agreement No 777119.