In vitro and in vivo hemocompatibility study of fish swim bladder-derived biomaterials for the application of chronic venous disease

Chronic venous disease (CVD) is a prevalent condition affecting the venous system of the lower limbs, characterized by venous hypertension and regurgitation resulting from congenital or acquired venous valve insufficiency. The global morbidity of CVD is as high as 69.94%. Prosthetic venous valve replacement provides a new therapeutic option. However, to mimic natural venous valves, the leaflets of prosthetic venous valves need to be as thin as ~200 μm, and better resistance to thrombosis is required due to the physiological characteristics of the venous system. Identifying suitable materials for the venous system is critical for the creation of prosthetic venous valves. Fish swim bladders have proper mechanical strength, durability and biocompatibility, making them one of the possible biomaterials for application in CVD. For the blood contact safety in the application of chronic venous disease, in vitro and in vivo studies were used to evaluate the blood compatibility, as specified in ISO 10993-4. The results showed that the swim bladder was comparable to the commercially available ePTFE material in the venous system and has the potential to be a raw material source for the development of medical devices for CVD.