Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System

Exclusion Criteria

• •Untreated significant superficial venous incompetence which, in the opinion of the Investigator, may be the primary source of existing symptoms;
• •Deep venous intervention in the target limb or outflow vessels within 6 months of consent;
• •Significant peripheral arterial disease with an ankle-brachial index of \<0.50 or with incompressible vessels;
• •Acute deep venous thrombosis (DVT) within 3 months of consent;
• •History of stroke within the last 6 months;
• •Flow-limiting venous outflow obstruction central to the intended target sites;
• •Insufficient inflow through the treatment vein upon manual augmentation;
• •Chronic, diffuse, post-thrombotic femoropopliteal vein disease that, in the Investigator's opinion, would preclude venous valve formation or would inhibit flow through the treatment sites;
• •Chronic renal insufficiency with creatinine level of ≥2mg/dL;
• •Hemoglobin level \<9.0 mg/dL;
• •Platelet count \<50,000 or \>1,000,000 per mm3;
• •Total white blood cell count \<3,000/mm3;
• •Pregnant or lactating female; positive pregnancy test, women of childbearing potential must be tested;
• •Non-ambulatory patients;