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Medical Devices Design in Cardiovascular Applications

Final Report Summary - MEDDICA (Medical Devices Design in Cardiovascular Applications)

Executive Summary:

MeDDiCA was a Marie Curie Initial Training Network designed to help young researchers develop careers in cardiovascular engineering and it was created to provide innovative training to PhD students and young postdoctoral researchers.The project has also helped these researchers to apply cutting-edge research techniques to the design and assessment of new medical devices by using computer modelling and simulation at the design phase to predict how new devices will work in a physiological environment.

The project focused on the development of models, analysis, validation and standards for medical devices.

UCL coordinated MeDDiCA’s pan-European consortium, which included engineering software company ANSYS/CFX, the University of Sheffield, the University of Amsterdam, the Technical University of Eindhoven, the Centre National de la Recherche Scientifique and the Université de Technologie de Compiègne, the Technical University of Cluj-Napoca, Politecnico di Milano and Istituto Superiore di Sanità.

MeDDiCA also collaborated with industrial partners in the medical devices industry, including Invatec, Hemolab and Nobil BioRicerche. MeDDiCA has also exploited its strong links with ‘Virtual Physiological Human Initiative’, providing world-class training via world-class research.

Main results:

MeDDiCA focused on cardiovascular devices and advanced the state of the art in different medical devices, including, heart valves, stents, aspiration catheters and left ventricular assist devices (LVADs). Within MeDDiCA, translation of in-silico and experimental techniques into the clinic or industry were of paramount importance. The main results will be summarised in the sections below:

- Knowledge Transfer (Industry): MeDDiCA partners collaborated with industry, in particular Medtronic-Invatec (an associate partner), ANSYS-CFX and Hemolab (now Lifetec Group). The outcomes of these collaborations is evidenced in several of the projects developed by MeDDiCA's Early Stage Researchers and the Experienced Researchers; in particular:

1.- Development of better models and new technologies for bio-inspired applications (ANSYS); including software and libraries to couple the software ANSYS/CFX with other mainstream software, such as Matlab. The progress made included the development of joint applications for better analysis of artero-venous fistulae, mechanical heart valves and the development of combined agent/finite element models.
2.- The analysis and improvement in the design of thrombus aspiration cathetehers: this will have a direct impact in the production of thombus aspiration cathethers for Medtronic-Invatech;
3.- The analysis of LVADs and their behaviour under normal and abnormal conditions (expanding the testing capabilities of the Hemolab ex-vivo platform).

- Knowledge Transfer (Clinical)

1.- The ERs and ESRs collaborated with different clinicians in different centres in order to further the understanding of the behaviour of medical devices (valves, stents, LVADs, catheters) and/or to improve their design. Specific collaborations were with clinicians as follows: Prof. Iancu Adrian Corneliu Institutul Inimii Niculae Stancioiu Cluj-Napoca, Romania; Mr. O. Agu, University College London Hospital; Mr. J. Gunn, Sheffield Teaching Hospitals.
2.- Participation in FDA meetings to assess the rupture of stents in specific patients.

All these collaborations are documented in the different deliverables of the project, the final list of publications and the MeDDiCA book.

- Benefits to the Academic Community:

1.- Advancement of the State of the Art: MeDDiCA produced a large number of scientific publications (with a number of publications still in preparation or submitted) that will benefit the scientific community as they truly represent an advancement of the state of the art in the design, assessment and simulation of medical devices. The list of publications is available in a separate section of this report.
2.- MeDDiCA Book: MeDDiCA produced a book (ISBN 978-0-957-6347-1-8) in which each chapter corresponds to an overal view of the work performed by our ERs and ESRs. This book puts in evidence the amount of work done by the MeDDiCA consortium in a unified volume. This book will be freely available from the MeDDiCA website.
3.- Training of highly-skilled researchers: The original idea of MeDDiCA was to provide high-quality training via high quality research to promising young researchers. MeDDiCA trained these researchers and many of them have already found positions in Industry or Academia. MeDDiCA has provided a network for them to develop and to count on and has rounded their knowledge by providing a holistic training programme, encompassing many disciplines.
4.- Special issue on the 'International Journal of Artificial Organs': MeDDiCA and MeDDiCA researchers will be the focus of a special issue of the 'International Journal of Artificial Organs', to be published in 2014.

Conclusions - potential impact and use:

The potential impact and use of the MeDDiCA research goes well beyond the Academic Centres participating in the project. The project engaged with a wide spectrum of stakeholders relevant for our work and which included Industry, Clinical Partners and Regulatory Agencies. In this respect, the results of the research are most promising and MeDDiCA managed to fulfil its objectives in terms of delivering impact by producing state of the art research with tangible results.

Socio-economic impact of the project.

This research is definitely important for Regulators and Policy Makers as it provides a forward-looking approach to medical devices. The EU market is that largest and most important market of medical devices in the world and the requirements to produce patient-specific treatment by well-informed citizens is constantly increasing. MeDDiCA has shown that it is possible to further the advancement of Medical Devices and at the same time, to start working on the individual analysis or development of them.