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VenaSeal Closure System got approval by FDA

The US Food and Drug Administration (FDA) has approved the VenaSeal closure system, first device to permanently treat varicose veins of leg by sealing them with an adhesive agent. The VenaSeal Closure system is manufactured by Covidien LLC, based in Morrisville, North Carolina.

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 cause enlarged, swollen or twisted leg. Patients with varicose veins may experience mild to moderate pain, blood clots, or skin ulcers; and in these cases compression stockings  is recommend treatment to remove or to close the affected veins.

The VenaSeal system is helpful in such condition. It is a sterile kit which is made up of an adhesive (n-butyl-2-cyanoacrylate), and delivery system components that include a catheter, guidewire, dispenser gun, dispenser tips, and syringes. Healthcare professional inserts the catheter through the skin into the diseased vein ad inject VenaSeal adhesive and then through ultrasound imaging they monitors proper placement of the catheter. This system is advantageous over other procedures which use drugs, laser, radio waves or cuts in the skin.

The U.S. clinical study assessed the safety and effectiveness of the VenaSeal system in 108 participants compared to radio-frequency ablation in 114 participants. The trials conclude that the  device is safe and effective for the treatment of symptomatic superficial varicose veins of the legs. The adverse condition may include vein inflammation (phlebitis) and burning or tingling (paresthesia) in the treatment zone. The VenaSeal system should not be used in patients who have a known hypersensitivity to the VenaSeal adhesive.


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