Feasibility of the InnoVein Valve and Delivery System for Chronic Venous Insufficiency

Key Inclusion Criteria: * Willing and able to provide written Informed Consent * Diagnosis of symptomatic non-obstructive chronic valvular insufficiency of the femoral vein * Willing and medically able to receive intraprocedural and post-procedural anticoagulation medication * Life expectancy \>1yr * Reflux time \>1s in the superficial femoral and/or popliteal vein Key Exclusion Criteria: * Any prior deep vein intervention within 6 months prior to the Index Procedure * History of 2+ DVTs * Inadequate inflow to the femoral vein or inadequate outflow through the femoral vein, iliac vein, or IVC * Current IVC Placement * History of pulmonary embolism within 6 months * Conditions that increase the risk of device thrombosis or patient bleeding * Any planned surgical or interventional procedure within 30 days prior to or after the Index Procedure * Investigator or sponsor believes the subject would not benefit, would not be appropriate, be unable to follow-up, or be at high risk for non-compliance with the protocol