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FDA Approves Closure System to Permanently Treat Varicose Veins
The FDA has approved the VenaSeal closure system (Covidien LLC) to permanently treat varicose veins of the legs by sealing the affected superficial veins using an adhesive agent.
Veins contain one-way valves that open to let blood flow through and then shut to keep blood from flowing backward. When valves in veins close to the skin (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 of 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 consists of an adhesive (a specially formulated n-butyl-2-cyanoacrylate) and delivery-system components, including a catheter, a guide wire, a 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 health care professional inserts the catheter through the skin into the diseased vein to allow injection of the VenaSeal adhesive, a clear liquid that polymerizes into a solid material. The health care 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, the agency’s pathway to evaluate the safety and effectiveness of class III medical devices. Data supporting the FDA approval included results from three clinical studies sponsored by the manufacturer. A U.S. study assessed the safety and effectiveness of the VenaSeal system in 108 participants compared with radio-frequency ablation in 114 participants. The trials showed that the device was 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 an acute whole-body infection. Adverse events observed in the U.S. trial included phlebitis and paresthesia in the treatment zone.
Source: FDA; February 20, 2015.