Kickoff event launches large Charité-led European collaboration
A digital kickoff event on January 14 and 15 marks the launch of ‘SIMCor’ (In silico testing and validation of cardiovascular implantable devices), a Horizon 2020 project coordinated by Charité – Universitätsmedizin Berlin. The aim of the project is to create a platform for the testing, development, and regulatory approval of cardiovascular implants. New methods such as computer simulations and virtual animal models are used, which contribute to an even better quality and safety of such implants. The collaborative project, which is funded by the European Union, will receive a total of € 7.2 million over three years. Nearly € 1 million of this funding will go to Charité.
Cardiovascular implantable medical devices are some of the most advanced, commonly used and life-sustaining implants. Their development, however, remains a major challenge. Computer-based (in silico) methods for the testing and validation of these devices – such as virtual animal models and computer modeling – can help to improve their quality, efficacy and safety while also reducing cost and time-to-market. Their use could improve access to treatment and minimize the need for in vivo studies (which involve the whole, living organism).
Funded as part of the Horizon 2020 program from January 2021, this collaboration involves 12 partners from eight countries and includes stakeholders from clinical practice, research, and industry. “We are firmly convinced that, through the use of computer simulation and virtual studies, SIMCor will speed up the development, validation and regulatory approval of cardiovascular medical devices,” says project coordinator Prof. Dr. Titus Kühne, Director of Charité’s Institute of Cardiovascular Modeling and Image-Guided Cardiovascular Interventions (ICM) and Research Group Lead at the German Heart Center Berlin (DHZB). He adds: “Our Institute is one of the drivers of innovation in the field of digital transformation.” Using an interdisciplinary approach and maintaining close links with clinical practice, the institute combines state-of-the-art imaging, data science and data modeling methods to lay the foundations for improvements in diagnostics, treatment planning and the clinical decision-making process.
The newly funded SIMCor project aims to establish a computer platform which will serve as a joint, open research and development resource for device manufacturers, medical institutes, and regulatory authorities. The idea is to support device validation along the entire research and development pathway – from in silico modeling to virtual animal and clinical studies. The processes involved will be used on device implants from two representative areas: transcatheter aortic valve implantation (TAVI) and pulmonary artery pressure sensors (PAPS). Results will be used to develop a best practice framework and standard operational procedures (SOPs).
The project will also develop a method for creating virtual patient groups known as cohorts. These will enable new implant devices to be tested using a range of geometries, pathological changes and clinical features which are relevant to both adult and pediatric patients. The aim is to make medical implants suitable for use in younger patients. SIMCor will also deliver device-specific models which are capable of predicting the safety, efficacy, and user-friendliness of medical devices.
The SIMCor collaboration
As a research and innovation measure, the SIMCor project receives funding under the European Commission’s Horizon 2020 program. Bringing together 12 partners from clinical centers, universities and industry, the project will be coordinated by Charité – Universitätsmedizin Berlin. Other European partners are: Lynkeus – Italy; Biotronik and the Institute for Implant Technology and Biomaterials (IIB) – Germany; the European Clinical Research Infrastructure Network (ECRIN) – France; the Institute for Advanced Studies and the Graz University of Technology – Austria; the Eindhoven University of Technology and Philips Electronics – Netherlands; the Transilvania University of Braşov – Romania; University College London – United Kingdom; and the Virtual Physiological Human Institute for Integrative Biomedical Research (VPH) – Belgium.
Links
Institute of Cardiovascular Modeling and Image-Guided Cardiovascular Interventions
Contact
Prof. Dr. Titus Kühne
Director, Institute of Cardiovascular Modeling and Image-Guided Cardiovascular Interventions
Charité – Universitätsmedizin Berlin
Tel: +49 30 450 553 882
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