The US Food and Drug Administration (FDA) has 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 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, guide-wire, 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, MD, Office of Device Evaluation, FDA's Center for Devices and Radiological Health, Rockville, Maryland. "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 3 medical devices. 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 in 108 participants compared with 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 included phlebitis and paraesthesia in the treatment zone.