OBJECTIVE: To evaluate the clinical performance of the Venclose radiofrequency system for thermal ablation of incompetent great saphenous veins.
MATERIALS AND METHODS: Twenty-five patients were enrolled and treated at the Vein Center at Brühl, Leipzig, Germany in a prospective exploratory study. Primary outcome measures were the percentage of limbs with vein occlusion without reflux in the treated vein and the number and type of adverse events through 12 months.
RESULTS: Four of 25 patients received bilateral great saphenous vein treatments (29 treated limbs). All patients completed the study through 12 months. Twenty-eight great saphenous veins (97%) were ablated and successfully occluded with no reflux while one vein developed segmental recanalization starting at the 3-month follow up. Six adverse events were reported through 12 months; two were determined by the investigator as probably related to the device or procedure. All adverse events were reported as resolved by 6 months.
CONCLUSION: In this exploratory study, use of the Venclose radiofrequency ablation system achieved vein occlusion without reflux in all but one vein with six adverse events treated and resolved.