NC Drug Company Gets FDA Approval for New Varicose Vein Treatment

NC Drug Company Gets FDA Approval for New Varicose Vein Treatment
February 23, 2015

A North Carolina-based drug company received approval last week for a new varicose vein treatment.

The U.S. Food and Drug Administration (FDA) approved VenaSeal, a system that permanently treats varicose veins by using an adhesive to seal the affected veins. The product is made by Covidien, based in Morrisville.

There are two types of veins—deep veins and superficial veins. Superficial veins are those that are close to the skin and the ones associated with varicose veins. All 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 these types of symptoms.

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.

The FDA reviewed data for the VenaSeal system in a premarket approval application. Data supporting the FDA approval included results from three clinical studies sponsored by the manufacturer. The U.S. clinical study assessed the safety and effectiveness of the VenaSeal system in 108 participants compared to radio-frequency ablation in 114 participants. The trials showed the device to be safe and effective for vein closure for the treatment of symptomatic superficial varicose veins of the legs.

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, and burning or tingling in the treatment zone.