At least 20% of patients undergoing cardiovascular bypass surgery lack suitable bypass material. This can be due to the patients vessel quality, previous operations or the unavailability of suitable prosthetic grafts. Currently small diameter vessels (<4.5 mm) such as the coronary artery, are not suitable for replacement by prosthetic grafts largely due to the low patency (risk of early occlusion and restenosis).
In Europe, the US and China alone there are about 12 million patients in need of a coronary artery and peripheral bypass grafting per year. 80% use at least one segment of autologous vein, therefore at least 20% is in clear need for an alternative to autologous materials. Besides the urgent need for small diameter grafts (coronary or peripheral vessels), there is also a considerable lack of replacement materials concerning large diameter vessels.
The artificial graft is a novel graft with high elasticity and a burst strength similar to a native vessel with a high patency rate. The invention at hand
aims to solve the current downsides by combining a metal-alloy supporting structure with a cellulose layer that has a unique patented inner structure. The modified inner structure is key for ideal endothelization, at the same time the structure remains fully permeable for cells while being blood tight. The anti thrombogenicity of cellulose is ideal also to prevent thrombosis. The graft is easy to handle storing at room temperature) ensuring good surgical handling at unlimited length.
Extensive patent portfolio with granted patents in numerous regions (including EP, US and China) some additional patents pending. Small scale manufacturing established. First results in porcines showed promising results after 3 months. Long term in-vivo porcine study planned.