FDA Approves Varicose Vein Closure System

The FDA today approved Sapheon’s VenaSeal closure system, the first device developed to permanently treat varicose veins of the legs by using an adhesive agent to seal the affected superficial veins.

The VenaSeal system consists of a catheter, guidewire, dispenser gun, dispenser tips, syringes, and specially formulated n-butyl-2-cyanoacrylate adhesive. The device is operated by inserting the catheter through the skin and into the affected vein to allow injection of the adhesive, which polymerizes into solid material and seals the vein.

The FDA based its nod on data from 3 manufacturer-sponsored clinical studies, including a US trial that evaluated the VenaSeal system’s safety and efficacy compared with radio-frequency ablation in 222 participants. The research team found the device to be safe and effective for vein closure in patients with symptomatic superficial varicose veins of the legs.

“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 press 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.”

The VenaSeal system is intended for patients with superficial varicose veins of the legs that cause symptoms, and 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 acute whole-body infection, according to an FDA press release. Adverse events observed in trial participants included vein inflammation and paresthesia in the treatment zone, though the FDA noted that these side effects were commonly associated with treatments of this condition.