VenaSeal Sapheon Closure System Pivotal Study (VeClose)

Exclusion Criteria

• •1. Life expectancy \< 1 year
• •2. Active treatment for malignancy other than non-melanoma skin cancer
• •3. Symptomatic peripheral arterial disease with ankle-brachial index (ABI) \<0.89
• •4. Daily use of narcotic or non-steroidal anti-inflammatory pain medications to control pain associated with GSV reflux
• •5. Current, regular use of systemic anticoagulation (e.g., warfarin, heparin)
• •6. Previous or suspected deep vein thrombosis (DVT) or pulmonary embolus (PE)
• •7. Previous superficial thrombophlebitis in GSV
• •8. Previous treatment of venous disease in target limb, other than spider vein treatment
• •9. Known hypercoagulable disorder
• •10. Conditions which prevent vein treatment with either RFA or VenaSeal SCS
• •11. Immobilization or inability to ambulate
• •12. Pregnant prior to enrollment
• •13. Tortuous GSV, which, in the opinion of the investigator, will limit catheter placement or require more than one primary access site
• •14. Aneurysm of the target vein with local diameter \>12 mm
• •15. Significant, incompetent, ipsilateral small saphenous, intersaphenous or anterior accessory great saphenous vein(s)
• •16. Known sensitivity to cyanoacrylate (CA) adhesives
• •17. Current participation in another clinical study involving an investigational agent or treatment, or within the 30 days prior to enrollment
• •18. Patients who require bilateral treatment during the next 3 months
• •19. Patients who require additional ipsilateral treatments on the same leg within 3 months following treatment