InterVene developed the BlueLeaf Endovenous Valve Formation (EVF) System, a novel approach to reconstruct venous valves using the patient's own tissue, offering a potential cure for chronic venous insufficiency. The BlueLeaf EVF System received FDA Breakthrough Device Designation in 2021. bioaccess® managed the first-in-human trials in Latin America.
Chronic venous insufficiency affects over 40 million Americans with no definitive cure. InterVene's autologous approach needed first-in-human validation to prove that reconstructed venous valves could restore competent venous flow, but US surgical trial costs and timelines were prohibitive.
bioaccess® identified vascular surgery centers in Colombia with expertise in venous reconstruction, managed regulatory and ethics approvals, coordinated surgical procedures, and oversaw duplex ultrasound and clinical outcome follow-up aligned with FDA expectations.