Human Trial Using The Novel Bioprosthetic Venovalve In Patients With Chronic Venous Insufficiency

Background: Chronic venous insufficiency (CVI) is a disease characterized by failure of the venous valves that allow blood from the lower limbs to return to the heart. The more severe types of CVI (C4b-C6 disease) significantly influence patients’quality of life (QOL). The treatment options for CVI of the deep system are limited.

The present study is the first-in-human study using a prosthetic venous valve, VenoValve, to initially evaluate patient outcomes. We evaluated the feasibility, initial safety, and performance outcomes of the VenoValve. Methods: Ten patients with C5-C6 CVI of the deep venous system secondary to post thrombotic syndrome had a VenoValve surgically implanted into the femoral vein in Bogota, Colombia, under approval of the local ethics committee and Colombian National Food and Drug Surveillance Institute, national health care regulatory body, or the Colombian National…