FDA Approves Covidien’s Varicose Vein Treatment

The FDA on Friday approved Covidien’s VenaSeal adhesive closure system for the permanent treatment of varicose veins in the legs.

The sterile consists of a specially formulated n-butyl-2-cyanoacrylate adhesive and a delivery system, which includes a catheter, guidewire, dispenser gun and tips, and syringes. The catheter is inserted through the skin into the diseased vein and adhesive is injected. Ultrasound is used to monitor the placement of the adhesive, which polymerizes into a solid in the affected vein.

The system is the first to treat varicose veins by sealing them with an adhesive, giving patients another treatment option for the condition, said William Maisel, acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. “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.

Approval was based on data from three clinical studies that assessed VenaSeal’s safety and effectiveness in 108 patients. — Kellen Owings