Covidien‘s VenaSeal closure system to treat varicose veins has been approved by the U.S. Food and Drug Administration, according to an agency press release.
The VenaSeal system, meanwhile, uses a medical adhesive, which is administered through a minimally invasive procedure that does not require tumescent anesthesia.
Covidien, which is now owned by Medtronic (NYSE:MDT) touted results of a study showing that its VenaSeal system is just as effective in treating chronic leg vein disorders as its ClosureFast ablation catheter back in November.
The randomized study, called VeClose, tracked 242 patients undergoing treatment of the great saphenous vein, a major superficial vein of the leg. After 6 months, the vein was still closed in 98.9% of the patients treated with VenaSeal, compared with 94.3% of those treated with ClosureFast.
The FDA approved the product under it more stringern premarket approval or PMA process.
“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,” William Maisel, acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health said in a prepared release. “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.”