Venclose digiRF System Post Market Study

Inclusion criteria

• Subject is age 18 and older
• Subject has CEAP clinical class C2 and higher.
• Has been diagnosed with refractory symptomatic disease attributable to the GSV/SSV or IPV to be treated.
• GSV/SSV or IPV to be treated that has an outward flow reflux duration of ≥ 0.5 seconds immediately after release of manual distal compression with subject standing or in Reverse Trendelenburg.
• For GSV/SSV cohort only: GSV/SSV to be treated in a leg that has a diameter ≥4.5 mm.
• For IPV cohort only: no more than two IPVs to be treated in a leg that have a diameter of ≥ 3.5 mm.
• For IPV only: IPVs must be located under a healed or active ulcer.
• Is able to ambulate.
• Is able to comprehend and has signed the Informed Consent Form (ICF) to participate in the study.
• Is willing and able to comply with the Clinical Investigation Plan and follow-up schedule.

Exclusion criteria

• Has had previous treatment for venous insufficiency in the same target vein.
• Has venous insufficiency secondary to venous obstruction proximal to the intended treatment site.
• Has thrombus in the vein segment to be treated.
• Has untreated critical limb ischemia from peripheral arterial disease.
• Is undergoing active anticoagulant therapy for acute Deep Vein Thrombosis or other conditions (e.g., warfarin, direct oral anticoagulant or low molecular weight heparin) or has a history of Deep Vein Thrombosis within the last 6 months or hypercoagulable state.
• Subjects with known bleeding and/or clotting disorders.
• Has ABI <0.8
• Subject is pregnant or breastfeeding
• For GSV/SSV only: has a BMI >35.
• For SSV only: has refluxing small saphenous vein thigh extensions (ex. Giacomini vein).
• Unable to ambulate, or restrictive ambulation.
• Has had prior venous procedures in the study limb within the last 30 days (including thrombolysis, thrombectomy, stenting, ablation, phlebectomy, visual or foam sclerotherapy).
• Has undergone or is expected to undergo any major surgery within 30 days prior to or following the study procedure.
• Has a condition, judged by the treating physician, that may jeopardize the subject's well-being and/or confound the results or the soundness of the study.