Seals the affected superficial veins using an adhesive agent
FRIDAY, Feb. 20, 2015 (HealthDay News) — The VenaSeal closure system has been approved by the U.S. Food and Drug Administration to treat superficial varicose veins of the legs that cause symptoms.
The system includes an adhesive; a specially formulated n-butyl-2-cyanoacrylate; and delivery system components, including a catheter, guidewire, dispenser gun, dispenser tips, and syringes. Ultrasound imaging is used to confirm proper placement of the catheter during delivery of the adhesive into the vein. The system was clinically evaluated in a study of more than 200 participants, comparing it to radio-frequency ablation. “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 FDA said Friday in a news release.
The VenaSeal system should not be used in people with a known sensitivity to the system’s adhesive, or in those with inflamed veins due to blood clots or acute whole-body infection. The most common side effects included vein inflammation and burning and tingling in the treatment area, the agency said.
“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,” 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, said in a statement.
The VenaSeal system is manufactured by Covidien, based in Morrisville, N.C.