FDA Approves Medtronic's Closure System To Permanently Treat Varicose Veins

(RTTNews) - The U.S. Food and Drug Administration said that it approved the VenaSeal closure system to permanently treat varicose veins of the legs by sealing the affected superficial veins using an adhesive agent. The VenaSeal Closure system is manufactured by Covidien LLC, based in Morrisville, North Carolina.

There are two types of veins—deep veins and superficial veins. Superficial veins are those that are close to the skin. Veins contain one-way valves that open to let blood flow through and then shut to keep blood from flowing backward. When valves of the superficial system are weak or damaged, blood can back up and pool, which can cause varicose veins that are enlarged, swollen or twisted.

Varicose veins often cause no symptoms but some patients may experience mild to moderate pain, blood clots, skin ulcers or other problems, according to the National Heart, Lung, and Blood Institute at the National Institutes of Health. If these issues occur, health care professionals may recommend treatment such as compression stockings or medical procedures to remove or close the affected veins.

The VenaSeal system is intended for patients with superficial varicose veins of the legs that cause symptoms. The sterile kit is made up of an adhesive, a specially formulated n-butyl-2-cyanoacrylate, and delivery system components that include a catheter, guidewire, dispenser gun, dispenser tips, and syringes.

The FDA noted that 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. 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 FDA warned that the VenaSeal system 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. Adverse events observed in the trial—and generally associated with treatments of this condition—included vein inflammation (phlebitis) and burning or tingling (paresthesia) in the treatment zone.

Medical device maker Medtronic plc. (MDT) completed its acquisition of Covidien in a cash and stock deal valued at about $49.9 billion on January 26. The deal was agreed upon in mid-June.