FDA Approves New System for Varicose Vein Treatment
The U.S. Food and Drug Administration (FDA) has approved the VenaSeal closure system for permanently treating varicose veins of the legs.
Intended for patients with superficial varicose veins of the legs that cause symptoms, the system—manufactured by Morrisville, N.C.-based Covidien LLC—seals the affected superficial veins using an adhesive agent. The system’s 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.
Chronic Venous Disease
Unilateral Superficial Venous Thrombosis
According to an FDA-issued statement announcing the system’s approval, 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.” With the VenaSeal system, 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, according to the FDA. Proper placement of the catheter is monitored using ultrasound imaging during delivery of the adhesive into the diseased vein to seal it.
The FDA reviewed data for the system in a pre-market approval application, with data supporting its approval including results from 3 clinical studies sponsored by the manufacturer. A U.S.-based 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,” according to the FDA, which cautions that the system 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 organization also notes that adverse events observed in the trial and typically associated with treatments of this condition included vein inflammation as well as burning or tingling of the treatment zone.
“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, MD, MPH, acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, 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.”