FDA clears closure system to permanently treat varicose veins

February 23, 2015

The VenaSeal system is newly approved to permanently treat varicose veins by sealing the affected veins using an adhesive agent, known as n-butyl-2-cyanoacrylate, which polymerizes into solid material after being injected into the vein.

FDA has approved VenaSeal closure system (Covidien LLC and Medtronic) to permanently treat varicose veins of the legs.

Varicose veins develop from superficial veins, which are those that are close to the skin. Veins contain 1-way valves that open to let blood flow through and then shut to keep blood from flowing backward. When valves of superficial veins are weak or damaged, blood can back up and pool, which can cause varicose veins that are enlarged, swollen or twisted. The most commonly affected veins are located in the legs or feet.

Patients with varicose veins may experience mild to moderate pain, blood clots, or skin ulcers; and in these cases health care professionals may recommend treatment such as compression stockings or medical procedures to remove or close the affected veins.

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The VenaSeal system is newly approved to permanently treat varicose veins by sealing the affected veins using an adhesive agent, known as n-butyl-2-cyanoacrylate, which polymerizes into solid material after being injected into the vein. It is intended for patients with varicose veins of the legs that cause symptoms. The product must be administered by a trained healthcare professional who must monitor proper placement of the catheter, which is used to deliver the adhesive.

“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 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.”

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FDA’s approval is based on 3 clinical studies, 1 of which was a US clinical study which assessed the safety and effectiveness of the VenaSeal system compared to radio-frequency ablation. The trials demonstrated that the device is 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 sensitivity to the adhesive, acute inflammation of the veins due to blood clots, or acute whole-body infection. Adverse reactions associated with the use of the device include vein inflammation, and burning or tingling of the treated area. 

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