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Leg Vein Health

Updated 28 January 2016

FDA clears device for treatment of varicose veins

The US Food and Drug Administration has approved a device to permanently treat symptomatic varicose veins of the legs.

The U.S. Food and Drug Administration approved a device to permanently treat symptomatic varicose veins of the legs.

Swollen veins

Varicose veins are swollen veins that are usually blue or dark purple. They often cause muscle cramps and an uncomfortable, heavy feeling in the affected area.

The VenaSeal closure system manufactured by Covidien LLC works by sealing the affected veins, using an adhesive agent injected through a catheter.

Read: What are varicose veins?

"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," Dr. William Maisel, acting director of the Office of Device Evaluation in the FDA's Centre for Devices and Radiological Health, said in a statement.

"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," he added.

VenaSeal system

The FDA reviewed data for the VenaSeal system in a premarket approval application, the agency's pathway to evaluate safety and effectiveness of Class III medical devices. Data supporting the FDA approval included results from three clinical studies sponsored by the manufacturer.

The trials showed the device to be safe and effective for vein closure for the treatment of symptomatic superficial varicose veins of the legs.

Read: Which varicose vein treatment is best?

The FDA says 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.

Adverse events observed in the trial-and generally associated with treatments of this condition-included vein inflammation (phlebitis) and burning or tingling (parestesia) in the treatment zone.

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