Transcatheter bicuspid venous valve prostheses: fluid mechanical performance testing of artificial nonwoven leaflets

Abstract Background Chronic venous insufficiency (CVI) is a common disease with a high prevalence. Incompetent venous valves are considered as one of the main causes. Besides compression therapy, various surgical therapies are practiced, whereby the reconstruction of valves is of central importance. There is an unmet clinical need, no valve prosthesis is commercially available to date. This work introduces two versions of a patented prosthetic bicuspid valve design made of electrospun thermoplastic silicone polycarbonate polyurethane (TSPCU) nanofiber leaflets attached in a nitinol stent, and their performance in static and pulsatile operation. Results The valves mainly fulfill the requirements widely accepted in literature. Valves of both versions were functional in the physiological pressure range up to 50 mmHg with design specific differences. Conclusions The here introduced design versions act as a platform technology and can be tailored for an intended implantation site. Evaluation of the original and modified valve concept demonstrated efficacy, with limitations at higher loads for original design. At the current state, the modification is preferable for fabrication, as one processing step is eliminated. Moreover, specific design recommendations could be drawn for valves of similar basic structure. Future work will focus on long-term performance and biocompatibility prior to the initiation of preclinical in vivo studies.