In-silico development- and clinical-trial-platform for testing in-situ tissue engineered vascular devices

Currently the standard treatment of diseased valves exhibiting functional impairment with clinical consequences is the replacement of the native valve with either a surgical valve or a transcatheter valve. These devices, which typically comprise leaflets and other components manufactured from processes animal tissue, suffer from age related structural deterioration or long-term calcification, making revision interventions occasionally necessary. Xeltis, a young startup company, has developed a new treatment paradigm during the past decade: the so-called Endogenous Tissue Restoration (ETR), which avoids animal-tissue derived leaflets and uses a synthetic polymer scaffold as the main component instead. The scaffold is manufactured from a supramolecular biodegradable polymer in combination with a fully controlled electrospinning process yielding a highly porous fibrous structure. The structural and material properties are optimized in such a way, that a finely tuned scaffolddegradation and simultaneous tissue regeneration process transform the synthetic ‘off-the-shelf-valve’ into a native-tissue heart valve, avoiding thereby the short-coming mentioned above.