Development and Comprehensive Evaluation of the First Polish, Second Generation, Thin Strut Biodegradable Polymer and Elastic, Sirolimus Eluting Vascular Stent

Project realised in the framework of the consortium composed of: American Heart of Poland Inc (consortium leader), Balton Ltd., Centre of Polymer and Carbon Materials of the Polish Academy of Sciences, Silesian University of Technology Faculty of Biomedical Engineering, Silesian Center for Heart Diseases, Military University of Technology, Innovations for Heart and Vessels Ltd.

The aim of the project is development and preclinical evaluation of new thin-strut biodegradable sirolimus eluting stent (PBES) as well as to verify its usefulness and therapeutic use in a preclinical studies

  • Total budget:

    Total budget:

    eligible costs 14,31 million PLN

    funding 11,45 million PLN

  • AHP budget

    AHP budget:

    eligible costs 2,88 million PLN

    funding 1,5 million PLN

  • Study period

    Study period:

    01.09.2015 - 31.08.2019

Novel drug eluting stents (DES) have led to reduction of coronary adverse events when compared to early DES, however late events caused by permanent implant remain to be addressed.

A fully bioresorbable DES, that scaffolds the vessel wall and disappears once the acute recoil and constrictive remodelling have subsided, has theoretical advantages and has shown promising results in pivotal clinical studies. Recent reports on scaffold thrombosis, caused by high profile of struts in the real world registries and cost remain the limitations of this therapy.

Therefore in cooperation with Polish field leaders in medical device industry, technology, translational research and medicine, we aim to introduce and evaluate the first polish, fully bioresorbable, thin strut, sirolimus eluting vascular stent (PBES) utilizing proprietary, fully biodegradable platform.

The prototype will be evaluated in the in-vivo preclinical setting, aiming to prove feasibility and safety with comprehensive evaluation of vascular healing, biocompatibility and polymer degradation in a series of large animal experiments. Finally, clinical implementation and certification steps will be executed.

Do góry