The Food and Drug Administration (FDA) has approved Covidien’s VenaSeal system for permanent treatment of varicose veins of the legs by sealing the affected superficial veins with an adhesive. The VenaSeal system is the first permanent treatment for varicose veins that uses an adhesive.
The VenaSeal system contains a specially formulated n-butyl-2-cyanoacrylate adhesive, and a delivery system that includes a catheter, guidewire, dispenser gun, dispenser tips, and syringes. The catheter is inserted through the skin into the affected vein for injection of the VenaSeal adhesive. The adhesive is a clear liquid that polymerizes into solid material, which seals the diseased vein.
The FDA’s approval is supported by data from three clinical studies. The United States clinical study evaluated the safety and efficacy of the VenaSeal system in 108 subjects vs. radio-frequency ablation in 114 subjects. The VenaSeal system safely and effectively sealed the vein to treat symptomatic superficial varicose veins of the legs.
For more information call or visit FDA.gov.