Simulation platform supports development of medical implants

EU joint project under Charité leadership starts with kick-off event

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The Horizon 2020 project SIMCor (In-silico testing and validation of cardiovascular implantable devices), coordinated by Charité – Universitätsmedizin Berlin, will start with a digital kick-off event on January 14 and 15. The aim of the project is to create a platform for the testing, development and approval of cardiovascular implants. New methods such as computer simulations and virtual animal models will be used to help improve the quality and safety of such implants. The collaborative project is funded by the European Union (EU) for a total of 7.2 million euros over three years, of which nearly 1 million euros is allocated to Charité.

Implantable medical cardiovascular devices are among the most advanced, widely used and life-sustaining implants. However, their development is a major challenge. Computer-based in silico methods for testing and validation – such as virtual animal models or computer models – can help improve the quality of such medical implants, increasing their efficacy and safety while reducing costs and development time. This can ultimately facilitate access to treatments and minimize the need for studies on living organisms.

The collaborative project, which will receive Horizon 2020 funding starting in early 2021, involves 12 partners from eight countries – clinical, academic and industrial. “We firmly believe that SIMCor will accelerate the development, validation and approval of cardiovascular medical devices through the use of computer simulations and virtual studies,” says project coordinator Prof. Dr. Titus Kühne, head of the Institute for Cardiovascular Computer-Assisted Medicine (ICM) at Charité and working group leader at the German Heart Institute Berlin (DHZB). “Our Institute for Cardiovascular Computer-Assisted Medicine is one of the innovation drivers in the field of digital transformation,” adds Prof. Kühne. Here, modern methods of imaging, data science and modelling are combined – in an interdisciplinary way and with a direct clinical reference – to develop the basis for improved diagnostics, therapy planning as well as decision support systems.

The SIMCor project, now funded, aims to establish a computing platform that will serve as an open resource for collaborative research and development among device manufacturers, medical institutions and regulatory agencies. Along the entire development process – from in silico modelling to virtual animal and clinical studies – device testing will be supported. As an example, these processes are applied to two representative cardiovascular implants: Transcatheter Aortic Valve Implants (TAVI) and Pulmonary Artery Pressure Sensors (PAPS), which will then be used to develop success methods and translate them into standard operating procedures (SOP).

The project will also develop a methodology for creating virtual patient groups – called cohorts – to test new implants with a variety of geometries, pathologically altered conditions, and clinical characteristics relevant to both adults and children. In this way, medical implants will be made useful for young patients in the future. In addition, SIMCor will provide device-specific models to predict the safety, efficacy and usability of medical devices.

The SIMCor joint project

The SIMCor collaborative project is funded by the European Commission as a research and innovation action under Horizon 2020. Charité – Universitätsmedizin Berlin is coordinating the collaboration of 12 partners from clinical centers, universities and industrial companies. Other European partners are Lynkeus in Italy, Biotronik and the Institute of Implant Technology and Biomaterials (IIB) in Germany, the European Clinical Research Infrastructure Network (ECRIN) in France, the Institute for Advanced Studies (IHS) and Graz University of Technology in Austria, Eindhoven University of Technology and Philips Electronics in the Netherlands, Transilvania University Braşov in Romania, the University College of London in the United Kingdom, and the Virtual Physiological Human Institute for Integrative Biomedical Research (VPH) in Belgium.