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In Silico testing and validation of Cardiovascular Implantable devices

Ziel

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.

Aufforderung zur Vorschlagseinreichung

H2020-SC1-DTH-2020-1
Andere Projekte für diesen Aufruf anzeigen

Finanzierungsplan

RIA - Research and Innovation action
Leaflet | Map data © OpenStreetMap contributors, Credit: EC-GISCO, © EuroGeographics for the administrative boundaries

Koordinator

CHARITE - UNIVERSITAETSMEDIZIN BERLIN
Adresse
Chariteplatz 1
10117 Berlin
Deutschland
Aktivitätstyp
Higher or Secondary Education Establishments
EU-Beitrag
€ 943 750

Beteiligte (11)

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