The Sapheon Closure System Feasibility Study

Inclusion Criteria:

• Males or non-pregnant females ≥21 years of age but <76 years of age.

• Venous reflux disease in the GSV diagnosed by clinical symptoms, with or withoutvisible varicosities, and confirmed by duplex ultrasound imaging.

• Candidate for surgical closure of a segment of the GSV.

• CEAP classification of C2, C3 or C4.

• Ability to walk unassisted.

• Life expectancy of at least 18 months.

• Weight >110 lbs. (50 kg).

• Ability to attend follow-up visits.

• Ability to understand the investigational nature of the treatment, and to providewritten informed consent.

Exclusion Criteria:

• Previous surgical procedure (surgical, thermal, or chemical ablation) associated withthe venous segment to be treated.

• Diameter of index vein (Supine) <3mm or >12 mm in any segment.

• Tortuous GSV, which in the opinion of the Investigator will limit catheter placement.

• Local or systemic infection.

• Insulin dependent diabetes.

• Leg obesity impairing the ability to gain access to the treatment leg, and/or applysufficient compression for treatment.

• Documented history of superficial or deep thrombophlebitis.

• Varicosities secondary to pelvic or abdominal tumor.

• Significant arterial insufficiency; demonstrated by absence of ankle pulse.

• Known sensitivity to the cyanoacrylate (CA) adhesive or positive reaction just priorto surgery (by injecting a small peripheral vein with the agent). The Study surgeonwill judge the need for the injection and the subject's reaction to the injection onclinical grounds.

• Formal duplication of the saphenous trunk in the index vein (Accessory GSV segmentsallowed).

• Hypercoaguable state.

• Presence of incompetent perforators in the treatment length.

• History of right ventricular failure.

• Significant femoral or popliteal vein insufficiency.

• BMI >35

• Additional procedures in the treatment leg likely required within the six months afterthe investigational procedure.

• Current participation in another clinical study involving an investigational agent ortreatment, or within the 30 days prior to enrollment.

• Other concurrent medical or other condition (chronic or acute in nature) that in theopinion of the Investigator may prevent safe participation or otherwise render thesubject ineligible for the Study.