The U.S. Food and Drug Administration (FDA) announced on Friday, Feb. 20, the approval of permanent varicose vein treatment VenaSeal, a closure system that seals affected superficial veins with a special adhesive agent.
Varicose veins usually cause no symptoms, but some have reported mild to moderate pain, skin ulcers, blood clots and other problems in their legs. They develop when one-way valves in superficial veins are damaged or weak, allowing blood to back up and lead to pooling, which enlarges, twists or swells the veins.
If compression stockings don't work, treatment mostly entails medical procedures aimed at removing or closing affected veins.
VenaSeal is designed for treating varicose vein patients experiencing symptoms. Aside from the n-butyl-2-cyanoacrylate adhesive, a special formulation, the closure kit also includes a delivery system comprised of syringes, a dispenser gun with tips, a guidewire and a catheter.
To apply the adhesive, trained medical personnel will insert the catheter into the affected vein. Clear liquid will flow into the vein and polymerize, solidifying to seal the vein up. To ensure the catheter is in the right position and the adhesive is being delivered properly, ultrasound imaging is utilized.
The VenaSeal system also doesn't use heat during the application or requires any sort of cutting so a patient experiences less bruising and is able to return to their normal day-to-day life quickly.
"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 FDA Office of Device Evaluation.
VenaSeal submitted an application for premarket approval, the FDA's pathway to evaluating safety and efficacy in Class III-type medical devices. The agency used data from three studies to support its approval, with at least one of the studies comparing VenaSeal's safety and efficacy against radio-frequency ablation.
According to all the clinical trials, VenaSeal is safe and effective for use in closing veins as a means of treating symptomatic superficial varicose veins in legs.
The FDA warns, however, that the system must not be used on patients with known sensitivity to n-butyl-2-cyanoacrylate, the adhesive VenaSeal uses, as well as those with acute vein inflammation due to whole-body infections or blood clots. Some of the adverse side effects reported in the clinical trials include tingling or burning (paresthesia) or inflammation (phlebitis) in the treatment area.
Covidien LLC is listed as manufacturer for VenaSeal.
