The U.S. Food and Drug Administration (FDA) has approved the VenaSeal closure system or the VenaSeal system to permanently treat varicose veins of the legs by sealing the affected superficial veins using an adhesive agent.

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.

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Varicose veins often cause no symptoms but some patients may experience mild to moderate pain, blood clots, skin ulcers or other problems. If these symptoms occur, health care professionals might 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 consists 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. It differs from other 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.

"This new system is the first to permanently treat varicose veins by sealing them with an adhesive, thereby giving patients another treatment option for this common condition," said William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation in the FDA's Center for Devices and Radiological Health.

"Because the VenaSeal system does not incorporate heat application or cutting, the in-office procedure can allow patients to quickly return to their normal activities, with less bruising."

The VenaSeal system should not be used in patients who have a known hypersensitivity to the VenaSeal adhesive, acute inflammation of the veins due to blood clots or acute whole-body infection.

The VenaSeal Closure system is manufactured by Covidien LLC, based in North Carolina.