FDA Approves New Varicose Vein Treatment

Megan Brooks


February 20, 2015

The US Food and Drug Administration (FDA) has approved the VenaSeal closure system (Covidien LLC), the first device to permanently treat varicose veins by sealing them with an adhesive agent.

Varicose veins often cause no symptoms, but some patients may experience mild to moderate pain, blood clots, skin ulcers, or other problems. In these cases, treatment may include compression stockings or medical procedures to remove or close the affected veins.

The VenaSeal system gives patients "another treatment option for this common condition," William Maisel, MD, MPH, acting director of the Office of Device Evaluation in the FDA's Center for Devices and Radiological Health, said in a news 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," he noted.

The VenaSeal system is intended for patients with symptomatic superficial varicose veins of the legs. The sterile kit includes a specially formulated n-butyl-2-cyanoacrylate adhesive, catheter, guidewire, dispenser gun, dispenser tips, and syringes.

"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," the FDA explains.

"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. The healthcare professional monitors proper placement of the catheter using ultrasound imaging during delivery of the adhesive into the diseased vein to seal it," the agency explains.

The FDA reviewed data for the VenaSeal system from three clinical studies sponsored by the manufacturer, which showed the device was safe and effective for the treatment of symptomatic superficial varicose veins of the legs.

The VenaSeal system should not be used in patients who have a known hypersensitivity to the VenaSeal adhesive, acute inflammation of the veins resulting from blood clots or acute whole-body infection. Adverse events observed in the trial, and generally associated with treatments for varicose veins, included phlebitis and paresthesia in the treatment area.


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