FDA approves VenaSeal system for treatment of varicose veins- Covidien

The FDA has approved the VenaSeal closure system (VenaSeal system) from Covidien, to permanently treat varicose veins of the legs by sealing the affected superficial veins using an adhesive agent. There are two types of veins�deep veins and superficial veins. Superficial veins are those that are close to the skin. Veins contain one-way valves that open to let blood flow through and then shut to keep blood from flowing backward. When valves of the superficial system are weak or damaged, blood can back up and pool, which can cause varicose veins that are enlarged, swollen or twisted.

Varicose veins often cause no symptoms but some patients may experience mild to moderate pain, blood clots, skin ulcers or other problems, according to the National Heart, Lung, and Blood Institute at the National Institutes of Health. If these issues occur, health care professionals may recommend treatment such as compression stockings or medical procedures to remove or close the affected veins.

The VenaSeal system is intended for patients with superficial varicose veins of the legs that cause symptoms. The sterile kit is made up of an adhesive, a specially formulated n-butyl-2-cyanoacrylate, and delivery system components that include a catheter, guidewire, dispenser gun, dispenser tips, and syringes. The device must be used as a system and differs from procedures that use drugs, laser, radio waves or cuts in the skin to close or remove veins. A trained healthcare professional inserts the catheter through the skin into the diseased vein to allow injection of the VenaSeal adhesive, a clear liquid that polymerizes into solid material. The healthcare professional monitors proper placement of the catheter using ultrasound imaging during delivery of the adhesive into the diseased vein to seal it.

Comment: The Vena Seal system received CE Mark in 2011.