Venclose digiRF System Post Market Study

Exclusion Criteria

• •1. Has had previous treatment for venous insufficiency in the same target vein.
• •2. Has venous insufficiency secondary to venous obstruction proximal to the intended treatment site.
• •3. Has thrombus in the vein segment to be treated.
• •4. Has untreated critical limb ischemia from peripheral arterial disease.
• •5. 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.
• •6. Subjects with known bleeding and/or clotting disorders.
• •7. Has ABI \<0.8
• •8. Subject is pregnant or breastfeeding
• •9. For GSV/SSV only: has a BMI \>35.
• •10. For SSV only: has refluxing small saphenous vein thigh extensions (ex. Giacomini vein).
• •11. Unable to ambulate, or restrictive ambulation.
• •12. Has had prior venous procedures in the study limb within the last 30 days (including thrombolysis, thrombectomy, stenting, ablation, phlebectomy, visual or foam sclerotherapy).
• •13. Has undergone or is expected to undergo any major surgery within 30 days prior to or following the study procedure.
• •14. 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.