The US Food and Drug Administration gave its nod to 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, NC.
The VenaSeal System is for patients with symptomatic superficial varicose veins of the legs. 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. The catheter is inserted through the skin into the diseased vein to allow injection of the VenaSeal adhesive, a clear liquid that polymerizes into solid material. Proper placement of the catheter is monitored via ultrasound imaging during delivery of the adhesive into the diseased vein to seal it.
The FDA reviewed data for the VenaSeal System in a premarket approval application. Data supporting the FDA approval included results from three clinical studies sponsored by the manufacturer. The US clinical study assessed the safety and effectiveness of the VenaSeal system among 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 phlebitis and paresthesia in the treatment zone.