Project description
In-silico prediction of safety and performance of a synthetic biodegradable heart valve
Valvular heart disease requires valve replacement or repair. Advances in tissue engineering offer the opportunity to develop a new class of heart valve replacements: synthetic biodegradable heart valves. To accelerate the development of these devices, the EU-funded SimInSitu project is proposing an in-silico model capable of predicting the device’s short- and long-term safety and performance. It will incorporate tissue-remodelling-algorithms, patient-specific-modelling, and device-modelling. All relevant components and processes will undergo an extensive verification, validation and uncertainty quantification programme to generate the necessary credibility and trustworthiness. The development of the in-silico model can facilitate the development of biodegradable devices, shorten the time to market, and contribute to development of a regulatory framework of in-silico methods.
Objective
SimInSitu is aiming to develop a sophisticated in-silico method to predict the short- and long-term behavior of in-situ tissue engineered heart valves by combing advanced tissue remodeling algorithms with a personalized virtual heart modelling approach. The method will be specifically developed to predict the complex transformation process of biodegradable heart valves from the initially synthetic scaffold into a fully remodeled & functional valve. This transformation process, named ETR for Endogenous Tissue Restoration, is the core technology for a new generation of very promising biodegradable vascular device currently developed by Xeltis. ETR makes the use of animal derived tissue, which is used in the majority of commercially available bioprosthetic heart valves, obsolete and avoids thereby durability related issues and potentially minimized the need for reoperations. Though, significant progress was made during the past years in developing ERT based devices, it remains very challenging, costly, time-consuming, and rich with obstacles. New knowledge can only be generated through a tedious trial & error process (requiring preclinical and clinical studies), since the restorative process cannot be replicated in an in-vitro environment. Advanced Computer Modelling & Simulation technologies have the potential to overcome this limitation by allowing to test new designs, modified scaffold compositions, or other applications in a virtual patient-specific environment – in-silico. SimInSitu will not only develop such a computer model, but will also verify and validate it thoroughly by making use of the extensive in-vitro and in-vivo data available and where necessary will generate new data to support the credibility of this in-silico method. The availability of this computer model could contribute significantly to an acceleration of especially the ETR-device development and accelerate their translation into the clinic and market.
Keywords
Project’s keywords as indicated by the project coordinator. Not to be confused with the EuroSciVoc taxonomy (Fields of science)
Project’s keywords as indicated by the project coordinator. Not to be confused with the EuroSciVoc taxonomy (Fields of science)
Programme(s)
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
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H2020-EU.3.1. - SOCIETAL CHALLENGES - Health, demographic change and well-being
MAIN PROGRAMME
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H2020-EU.3.1.5.3. - Using in-silico medicine for improving disease management and prediction
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Topic(s)
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Funding Scheme
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
RIA - Research and Innovation action
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Call for proposal
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
(opens in new window) H2020-SC1-DTH-2018-2020
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Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
3401 NJ IJSSELSTEIN
Netherlands
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.