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 oftheir CVI management (symptoms not adequately resolved or patientnon-compliant/unable to tolerate)

• Deep system venous reflux characterized by >1 second reflux time in two veinsegments (vein segments defined as: proximal femoral, distal femoral, andpopliteal), as assessed by duplex ultrasound (DUS) with patient in the standingposition

• Presence of at least two potential target sites within a target vessel as assessedpreliminarily by DUS, with a target site being defined as a segment within thefemoral or popliteal vein that is:

7mm to 11mm in luminal diameter and at least 3cm long and absent features that, inthe Investigator's opinion, would preclude formation of a monocuspid valve (at anyorientation).

• In the Investigator's opinion, the subject is a good candidate for treatment withthe BlueLeaf System based on their symptoms, quality of life, anatomy, and thelikelihood of benefit from continued conservative therapy

Key Exclusion Criteria:

• Untreated significant superficial venous incompetence which, in the opinion of theInvestigator, 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 vesselswithin 3 months of consent

• Flow-limiting venous outflow obstruction central to the intended target sites,defined by a common femoral vein duplex exam found to have a continuous waveformwithout respiratory variation

• Contraindications to all protocol specified anticoagulation options

• Known and uncontrolled hypercoagulopathy (i.e. hypercoagulopathy that cannot beadequately managed/controlled with medication)

• Women on long-term oral contraceptives

• Non-ambulatory patients

• Significant peripheral arterial disease with an ankle-brachial index of < 0.70 orwith incompressible vessels

• New York Heart Association Class III or IV heart failure

• Patients with a history of right heart failure occurring as a consequence of, forexample, biventricular failure, intrinsic pulmonary disease, chronic thromboembolicpulmonary hypertension, and other etiologies that result in elevated right-sidedpressures.

• Active systemic infection

• Invasive surgical procedure within the last 3 months that in the Investigator'sopinion would interfere with the study procedure or results

• Chronic renal insufficiency with creatinine level of ≥ 2mg/dL

• Hemoglobin level < 9.0 mg/dL

• Platelet count < 50,000 or > 1,000,000/mm3

• Total white blood cell count < 3,000/mm3

• Subject is enrolled in another clinical study that, in the opinion of theInvestigator, may conflict with this study or compromise study results

• Comorbidity risks or other concerns which, in the opinion of the Investigator,either limits longevity or likelihood of complying with the protocol and itsprescribed follow up (e.g. recent cancer or stroke); or precludes patient from beingtransitioned to open surgery if complication requiring surgical intervention occursduring the procedure (such as severe vein laceration).