Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System (INFINITE-US)

Key Inclusion Criteria * Failed at least 6 months of conservative therapy at some point during the course of their CVI management (symptoms not adequately resolved or patient non-compliant/unable to tolerate) * Deep system venous reflux characterized by \>1 second reflux time in two vein segments (vein segments defined as: proximal femoral, distal femoral, and popliteal), as assessed by duplex ultrasound (DUS) with patient in the standing position * Presence of at least two potential target sites within a target vessel as assessed preliminarily by DUS, with a target site being defined as a segment within the femoral or popliteal vein that is: 7mm to 11mm in luminal diameter and at least 3cm long and absent features that, in the Investigator's opinion, would preclude formation of a monocuspid valve (at any orientation). * In the Investigator's opinion, the subject is a good candidate for treatment with the BlueLeaf System based on their symptoms, quality of life, anatomy, and the likelihood of benefit from continued conservative therapy Key Exclusion Criteria: * Untreated significant superficial venous incompetence which, in the opinion of the Investigator, may be the primary source of existing symptoms * Acute deep venous thrombosis (DVT) within 1 year of consent * Deep venous intervention (includes stenting) in the target limb or outflow vessels within 3 months of consent * Flow-limiting venous outflow obstruction central to the intended target sites, defined by a comm…