A new kind of treatment which has already been approved by the US Food and Drug Administration (FDA) is now being used to permanently treat varicose veins. The VenaSeal closure system (Covidien LLC) is the first procedure to permanently treat varicose veins through sealing them with an adhesive agent.
In most patients, varicose veins may not give them any discomfort like mild to moderate pain, blood clots, skin ulcers, or other problems. On the other hand, patients suffering from these may be given a treatment that includes compression stockings or medical procedures to remove or close the affected veins.
The VenaSeal system offers their patients with “another treatment option for this common condition”, said the acting director of the Office of the device Evaluation in the FDA’s Center for Devices and Radiological Health, William Maisel stated in a news release. ”Because the VenaSeal system does not incorporate heat application cutting, the in-office procedure can allow patients to quickly return to their normal activities, with less bruising.”
The VenaSeal system is suitable for patients with symptomatic superficial varicose veins of the legs. The kit contains a specially formulated n-butyl-2-cyanoacrylate adhesive, catheter guide wire, 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 clarified.
“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 explained.
Based on the data that was reviewed by the DFA for the VenaSeal system that came from three clinical studies sponsored by the manufacturer, it was known that the device is a safe and effective remedy of symptomatic superficial varicose veins of the legs.
However, to those patients who have hypersensitivity to the VenaSeal adhesive, acute inflammation of the veins resulting from blood clots, or acute whole-body infection: there may have been some unfavorable incidents in the trial, and is mainly involved with treatments for the varicose veins, which include phlebitis: the inflammation of the walls of the vein and paresthesia or tingling sensation in the treatment area.