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In Silico testing and validation of Cardiovascular Implantable devices

Objective

The complexity and speed of technological innovation, with increasingly short product cycles, creates huge demand for standardized best practices to apply in-silico validation methods in a statistically robust, repeatable, and efficient way. SIMCor will address this challenge by providing manufacturers of cardiovascular implantable devices with an open, reusable, cloud-based platform for in-silico testing to accelerate development and regulatory approval of their products. The platform will support device validation along the whole R&D pipeline: from initial modelling and in vitro experiments, to animal studies and device implantation and effect simulation on human cohorts. In particular, SIMCor innovative virtual cohort technology will allow to generate and expose new or existing devices to a range of clinically realistic and diversified anatomies and (patho)physiological conditions, also including extensive paediatric populations, meeting the critical need of testing devices in young patients. A standardized multi-level validation process and sensitivity analysis will guarantee statistical credibility for in-silico tests and the platform as a whole, proving solid experimental ground for regulatory authorities, thus accelerating approval and time to market for new products, reducing the burden of human and animal studies and boosting innovation at large. High-priority safety, efficacy and usability endpoints will be investigated, focusing on device implantation and effect simulations in two representative areas: transcatheter aortic valve implantation (TAVI) and pulmonary artery pressure sensors (PAPS). Based on proof-of-validation results and regulatory approval for these use cases, SIMCor will define standard operational procedures (SOPs) and a generalised technical framework for the in-silico testing, validation and regulatory approval of cardiovascular devices, to be put at the service of researchers, medical device manufacturers and regulatory bodies.

Call for proposal

H2020-SC1-DTH-2020-1
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Funding Scheme

RIA - Research and Innovation action

Coordinator

CHARITE - UNIVERSITAETSMEDIZIN BERLIN
Address
Chariteplatz 1
10117 Berlin
Germany
Activity type
Higher or Secondary Education Establishments
EU contribution
€ 943 750

Participants (11)

LYNKEUS
Italy
EU contribution
€ 655 625
Address
Livenza 6
00198 Rome
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
BIOTRONIK SE & CO. KG
Germany
EU contribution
€ 942 156,25
Address
Woermannkehre 1
12359 Berlin
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK
France
EU contribution
€ 410 625
Address
5 Rue Watt
75013 Paris
Activity type
Research Organisations
INSTITUT FUER HOEHERE STUDIEN - INSTITUTE FOR ADVANCED STUDIES
Austria
EU contribution
€ 514 756,25
Address
Josefstaedter Strasse 39
1080 Wien
Activity type
Higher or Secondary Education Establishments
INSTITUT FUR IMPLANTATTECHNOLOGIE UND BIOMATERIALIEN EV
Germany
EU contribution
€ 667 456,25
Address
Friedrich-barnewitz-strasse 4
18119 Rostock
Activity type
Research Organisations
PHILIPS ELECTRONICS NEDERLAND BV
Netherlands
EU contribution
€ 581 750
Address
High Tech Campus 52
5656 AG Eindhoven
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
TECHNISCHE UNIVERSITEIT EINDHOVEN
Netherlands
EU contribution
€ 703 437,50
Address
Groene Loper 3
5612 AE Eindhoven
Activity type
Higher or Secondary Education Establishments
TECHNISCHE UNIVERSITAET GRAZ
Austria
EU contribution
€ 684 250
Address
Rechbauerstrasse 12
8010 Graz
Activity type
Higher or Secondary Education Establishments
UNIVERSITATEA TRANSILVANIA DIN BRASOV
Romania
EU contribution
€ 317 750
Address
Bdul Eroilor 29
500036 Brasov
Activity type
Higher or Secondary Education Establishments
UNIVERSITY COLLEGE LONDON
United Kingdom
EU contribution
€ 528 175
Address
Gower Street
WC1E 6BT London
Activity type
Higher or Secondary Education Establishments
VIRTUAL PHYSIOLOGICAL HUMAN INSTITUTE FOR INTEGRATIVE BIOMEDICAL RESEARCH VZW
Belgium
EU contribution
€ 310 625
Address
Celestijnenlaan 300C
3001 Heverlee
Activity type
Research Organisations