NeoVena: A Bioresorbable Polymeric Venous Valve

Obiettivo

Chronic Venous Insufficiency (CVI) is a highly prevalent and debilitating vascular disorder affecting more than 200 million people worldwide. CVI develops when venous valves in the legs fail, leading to reflux, venous hypertension, blood pooling, pain, edema, skin changes, and, in severe cases, non-healing ulcers. Current treatments such as compression stockings, venoplasty, or bypass surgery alleviate symptoms but do not restore valve function, and despite decades of research there is still no approved prosthetic venous valve available. Existing approaches using permanent metallic frames or tissue-based constructs face major limitations, including thrombosis risk, chronic inflammation, infection, and eventual device failure.
We propose NeoVena, a first-in-class fully bioresorbable polymeric venous valve that provides immediate restoration of unidirectional blood flow while serving as a temporary regenerative scaffold. Building on the ERC-funded project TAVI4Life, which developed a bioresorbable stent platform with excellent elasticity and hemodynamic performance for heart valve applications, we adapted this technology to create the first NeoVena prototypes. Fabricated via precision 3D-printing, NeoVena integrates a bioresorbable stent with a polymeric valve leaflet scaffold. Over time, the synthetic components gradually degrade and are safely resorbed, leaving behind a functional, living, native-like venous valve. This regenerative approach avoids the long-term complications associated with permanent implants while directly addressing the root cause of CVI.
This ERC Proof of Concept project will establish the feasibility of NeoVena by refining its design, fabricating prototypes through scalable additive manufacturing, and validating their performance in vitro and in vivo. Ultimately, NeoVena aims to bridge the gap between fundamental biomaterials research and a clinically relevant solution for patients suffering from CVI.