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ObjectiveThe purpose of this study was to assess the safety and efficacy of the ClariVein® system that employs mechanochemical ablation of the great saphenous vein (GSV).MethodPatients eligible for ablation of the GSV underwent micropuncture access with only local anaesthesia to insert a 4 or 5 Fr sheath. The ClariVein® catheter was placed through the sheath, the wire was extruded, and the distal tip of the wire positioned 2 cm from the saphenofemoral junction under ultrasound guidance. Catheter wire rotation was then activated for 2–3 seconds at approximately 3500 rpm. With the wire rotating, infusion of the sclerosant was started simultaneously with catheter pullback. The sclerosant used was 1.5% liquid sodium tetradecyl sulphate (Sotradecol©, Bioniche Pharma Group, Geneva, Switzerland).ResultsThirty GSVs in 29 patients were treated. All patients have reached six-month follow-up; the average number of postoperative days is 260. No adverse events have been reported. The Primary Closure Rate is 96.7%.ConclusionMechanochemical ablation appears to be safe and efficacious. The ClariVein® technique eliminates the need for tumescent anaesthesia. The great majority of incompetent GSVs can be treated with this technique.

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The 2 primary objectives of this study were to investigate whether the 1470-nm wavelength can close a saphenous vein painlessly and determine safety, efficacy, and side effects of the 1470-nm laser. In all, 26 limbs were treated in the Dominican Republic, with a radially-emitting fiber at low energy ranging from 20 J/cm to 30 J/cm. Perivenous anesthesia was used selectively. Then 41 veins were treated with the 1470-nm laser at 30 J/cm at 5 watts, using standard perivenous tumescent anesthesia in Miami and compared to a historical control (980 nm, 80 J/cm, and 12 watts). We demonstrated that the 1470-nm wavelength endovenous laser system could not close saphenous veins without use of anesthesia. Closure with a dramatic reduction in energy when compared to a 980-nm wavelength control demonstrated a marked reduction in postoperative pain and ecchymosis; this implies that vein-wall perforations are minimized with this system.