FDA approves VenaSeal system to permanently treat varicose veins

The FDA today announced its approval of 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 leg that cause symptoms such as pain, blood clots, skin ulcers or other problems, according to an FDA press release.

The kit comprises an adhesive, a specially formulated n-butyl-2-cyanoacrylate and delivery system components that include a catheter, guidewire, dispenser gun, dispenser tips and syringes.

A trained health care professional inserts the catheter through the skin into the diseased vein to allow injection of the VenaSeal adhesive, a clear liquid that polymerizes into a solid material. Proper placement of the catheter is monitored using ultrasound imaging during delivery of the adhesive.

The FDA approval is based upon data from three clinical studies sponsored by the manufacturer. Among these, the U.S. clinical study assessed the safety and efficacy of the VenaSeal system in 108 participants compared with radio-frequency ablation in 114 participants. The device was found to be safe and effective for vein closure in the trials, according to the release.

The FDA stated the system should not be used in patients with a known hypersensitivity to VenaSeal adhesive, acute inflammation of the veins due to blood clots or acute whole-body infection.

Adverse events observed during the trial, and those generally associated with treatments for this condition, included vein inflammation and burning or tingling sensation in the treated area, according to the release.

Reference: www.fda.gov.