The U.S. Food and Drug Administration today approved the VenaSeal closure system (VenaSeal system) to permanently treat varicose veins of the legs by sealing the affected superficial veins using an adhesive agent.
Image/National Heart Lung and Blood Institute
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 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.
“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, M.D., M.P.H., acting director of the Office of Device Evaluation in the 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.”
The FDA reviewed data for the VenaSeal system in a premarket approval application, the agency’s pathway to evaluate safety and effectiveness of Class III medical devices. Data supporting the FDA approval included results from three clinical studies sponsored by the manufacturer. 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 showed the device to be safe and effective for vein closure 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 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.
The VenaSeal Closure system is manufactured by Covidien LLC, based in Morrisville, North Carolina.
Varicose veins frequently cause no side effects except for certain patients may encounter gentle to direct torment, blood clumps, skin ulcers or different issues, as per the National Heart, Lung, and Blood Institute at the National Institutes of Health. In the event that these issues happen, medical care experts may suggest therapy like pressure stockings or operations to eliminate or close the influenced veins.
The VenaSeal framework is expected for patients with shallow varicose veins of the legs that cause indications. The sterile unit is comprised of a glue, an extraordinarily figured n-butyl-2-cyanoacrylate, and conveyance framework parts that incorporate a catheter, guidewire, distributor weapon, allocator tips, and needles.
The gadget should be utilized as a framework and varies from methods that utilization drugs, laser, radio waves or slices in the skin to close or eliminate veins. A prepared medical care proficient supplements the catheter through the skin into the sick vein to permit infusion of the VenaSeal glue, an unmistakable fluid that polymerizes into strong material. The medical care proficient screens appropriate arrangement of the catheter utilizing ultrasound imaging during conveyance of the glue into the sick vein to seal it.
“This new framework is quick to for all time treat varicose veins via fixing them with a cement, accordingly giving patients another treatment alternative for this normal condition,” said William Maisel, M.D., M.P.H., acting overseer of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. “Since the VenaSeal framework doesn’t join heat application or cutting, the in-office system can permit patients to rapidly get back to their ordinary exercises, with less wounding.”
The FDA checked on information for the VenaSeal framework in a premarket endorsement application, the office’s pathway to assess security and adequacy of Class III clinical gadgets. Information supporting the FDA endorsement included outcomes from three clinical examinations supported by the producer. The U.S. clinical examination evaluated the wellbeing and viability of the VenaSeal framework in 108 members contrasted with radio-recurrence removal in 114 members. The preliminaries demonstrated the gadget to be protected and powerful for vein conclusion for the treatment of suggestive shallow varicose veins of the legs.