Development and implementation of the first Polish transcatheter
low-profile aortic valve

The project implemented by the consortium CardValve composed of American Heart of Poland Inc (Leader), Balton Sp. o.o., Silesian Center for Heart Diseases, Centre of Polymer and Carbon Materials Sciences, Silesian University of Technology, Innovations for Heart and Vessels Sp. o.o., Institute of Animal PIB.

The aim of the project is to create a new generation low-profile, balloon-expandable and self-positioning transcatheter aortic valve “InFlow” by using new composite and biological materials.

  • Total budget

    Total budget:
    eligible costs 14,8 million PLN
    funding 11,6 million PLN

  • AHP budget

    AHP budget:
    eligible costs 1,4 million PLN
    funding 0,7 million PLN

  • Study period:

    Study period:
    01.11.2014 - 31.07.2018

Surgical aortic valve (AV) replacement (AVR) is a gold standard for treatment of severe aortic stenosis (AS), however almost 1/3 of patients especially elderly, are not treated. The main reason is high periprocedural mortality caused by multiple risk factors in particular in patients older than 75 years in whom incidence of AS is almost 14%.

Although transcatheter AV implantation (TAVI) proved safe and efficient treatment of patients disqualified from AVR, substantial limitations such as high costs, complexity, bulky delivery systems and high risk of complications limit their widespread use.

The project aim is to develop the first Polish balloon-expandable, low-profile transcatheter AV using ultra low profile delivery system which would reduce the procedure-related adverse outcomes and costs, increase availability of TAVI and increase the competiveness of Polish companies.

The project is implemented in cooperation with leaders in cardiology, cardiac surgery, industry and science, having wide experience in medical technologies.

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