Minimally Invasive Treatment of Primary Great Saphenous Vein (GSV) Insufficiency Using High Intensity Focused Ultrasound (HIFU)

Inclusion Criteria

• •1. Candidate for venous procedure with primary GSV insufficiency involving reflux in the segment to be treated
• •2. CEAP-clinical classification ≥ 2
• •3. Physical condition allowing ambulation after the procedure.
• •4. Agree to comply with the Clinical investigation plan and follow-up schedule of the study
• •5. Targeted tissue reachable for treatment with the device - meaning between 5mm and 24mm below the skin surface.
• •6. Age over 22 years at the time of enrollment.
• •7. No acute venous thrombosis.
• •8. No complete or near complete deep vein post-thrombotic disease.
• •9. Patient has signed and understood the written informed consent.