IDE allows Irvine, California–based enVVeno  (formerly Hancock Jaffe) to begin the TAVVE pivotal trial for the system. It represents a first-in-class minimally invasive, non-surgical replacement venous valve for patients suffering from severe deep chronic venous insufficiency (CVI).

enVVe, a non-surgical valve, features a self-expanding nitinol frame. Its unique single-leaflet design — laser cut from porcine pericardium tissue — and a low-profile 13 Fr delivery system when crimped make up the rest of the small-profile valve.