SimInSitu aims to develop the first in-silico clinical trial and development platform able to predict the short- and long-term response of tissue engineered heart valves (TEHVs) in-situ in humans. This will enable the virtual clinical evaluation and optimisation of TEHV performance and safety through a multidisciplinary approach that combines advanced patient-specific computational models, tissue remodelling and growth algorithms, and device-specific models.

Advanced computer modelling and simulation technologies have the potential to accelerate the medical device development and clinical evaluation process and to reduce time and cost to market if adequate credibility and reliability can be demonstrated. SimInSitu will also assess and document the credibility and reliability of the platform following a hierarchical approach to development and validation within a design-like environment. Extensive model verifications, validation and uncertainty propagation assessments at several levels of complexity will make use of a multitude of bench-scale, in vitro and in vivo test data to build the necessary evidence.

SimInSitu will work with regulators, international initiatives, industry leaders and other consortia to help develop the required in-silico regulatory framework.

Thanks to the synergies and experience of the consortium and the expertise of its external advisors, the SimInSitu project can draw on a broad range of cross-disciplinary technological, biomedical, clinical and regulatory knowledge.

List of Participants:

1. 4RealSim Services BV - NL

2. University of Palermo - Engineering - IT

3. Armines/Mines Sint Etienne - Soft Tissue Biomechanics - FR

4. Leartiker, S.Coop - ES

5. Xeltis BV - NL

6. Capvidia NV - NL

7. Graz University of Technology - Institute of Biomechanics - AT

8. KU-Leuven - Soft Tissue Biomechanics - BE

9. KU-Leuven - Cardiac Surgery - BE

Key Advisers:

Michaels S. Sacks - Professor of Biomedical Engineering - University of Texas at Austin

Jean-François Imbert - Founding Director - SIMconcept Consulting

Javad Fatemi - Airbus Space and Defence Expert - Airbus Defence and Space Netherlands

The development of the in-silico SimInSitu method is based on three main development tracks, which are independent at first but converge over time into a unified platform. These three initial development tracks can be classified into device modelling, patient-specific modelling and ETR (Endogenous Tissue Regeneration) modelling. Device modelling encompasses the characterisation of scaffolds, scaffold modelling and device modelling. Leartiker's work package will focus on the characterisation of the synthetic scaffold architecture.