On 31 December 2021, SIMCor (In-Silico testing and validation of Cardiovascular IMplantable devices) concluded its 1st year of implementation. Dates aside, much has been accomplished during this first year of activity, with promising results that encourage the consortium to be confident on the prosecution of the project and the midterm review with the European Commission, to be held in September 2022.
SIMCor is a 3-year (1 January 2021 – 31 December 2023), 7.2 M€ Research and Innovation Action (RIA) funded under the topic Accelerating the uptake of computer simulations for testing medicines and medical devices (SC1-DTH-06-2020) of the call Digital transformation in Health and Care (H2020-SC1-DTH-2018-2020), as part of the Health, Demographic Change and Wellbeing area of the Horizon 2020 Framework Programme.
Its consortium is coordinated by Charité – Universitätsmedizin Berlin, and consists of 12 partners from 8 countries, including clinical centres, academia, industry and SMEs.
The project is implementing a collaborative platform for the in-silico development, validation and regulatory approval of cardiovascular devices, at the service of device manufacturers, clinical researchers, medical authorities and regulatory bodies.
The platform will be equipped with a variety of tools such as synthetic data, virtual cohorts of patients and animal models, simulation models for virtual implantation and safety, efficacy and usability assessment, to be developed and validated in the course of the project. The consortium is also formulating standard operating procedures and guidelines, to be formulated and discussed with relevant regulatory authorities (Team NB, ISO, EMA, FDA) through Advisory Boards and other engagement initiatives under the lead of the VPH Institute.
SIMCor specifically focuses on two clinical use cases, transcatheter aortic valve implantation (TAVI) and pulmonary artery pressure sensors (PAPS). The former (TAVI) represents a less-invasive procedure for aortic valve replacement for the treatment of aortic valve disease. The latter (PAPS) constitutes an implantable, wireless monitoring system for blood flow dynamics and intra-cardiac pressure monitoring for heart failure patients.
After the initial requirement elicitation and ethical approval phase (Phase 1, M1-M6), the project is now in its Phase 2 (M6-M18), dedicated to the development of in-silico modeling resources. The consortium has successfully deployed its virtual research environment (VRE) drive for sharing of data between partners, as well as a first database of processed geometries and boundary conditions. Also, it has defined the desired output variables of interests, simulation models and input space for virtual cohort generation, and it has designed the initial TAVI and PAPS device models. It has also finalised the first version of the standard operating procedures for data processing and the guidelines for documentation for in-silico models, to be submitted for feedback in the next months to the relevant Regulatory Advisory Board.