Closure System Permanently Seals Varicose Veins

The VenaSeal Closure System is composed of a specially formulated adhesive (n-butyl-2-cyanoacrylate) and a delivery system that includes a catheter, guidewire, dispenser gun, dispenser tips, and syringes. The VenaSeal Closure System does not require tumescent anesthesia to be injected peripherally into the leg, and because there are no pre-procedures drugs involved, patients can usually return to their normal activities right after the treatment, with just a Band-Aid in place.

For example, to seal the great saphenous vein (GSV), the catheter is first guided via ultrasound (US) towards the saphenofemoral junction (SFJ); once properly placed near the SFJ, the adhesive is injected into the lumen, sealing the vein. The procedure is then repeated every three cm along the GSV. Once closed, blood is immediately rerouted through other healthy veins in the leg. The VenaSeal Closure system is a product of Sapheon (Morrisville, NC, USA), a part of Covidien (Dublin, Ireland), and has been approved by the US Food and Drug Administration (FDA).

“Cyanoacrylate embolization is an effective and durable solution to the problem of incompetent great saphenous veins; long-term effectiveness is high,” said Prof. Thomas Proebstle, MD, of Mainz University (Germany), who led the European multicenter clinical study of the system. “The elimination of the need for perivenous tumescent anesthesia and post-interventional compression stockings, along with the associated side effects, results in significantly improved treatment.”

“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, MPH, acting director of the office of device evaluation in the FDA’s Center for Devices and Radiological Health (CDRH). “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.”

Varicose veins (also known as venous reflux disease) occur when valves inside the veins break and blood is unable to circulate properly. This is a common condition that affects both men (25%) and women (40%). Varicose veins can occur anywhere from the groin to the ankle.

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Sapheon
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