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.