New Foam Treatment of Varicose Veins

In November of 2013, the US Food and Drug Administration (FDA)  approved Varithena,^™   a new type of foam treatment for the treatment of patients with incompetent veins and visible varicosities of the great saphenous vein (GSV) system. Varithena^™ is a pharmaceutical-grade, low-nitrogen, polidocanol foam dispensed from a canister device. In two pivotal, placebo-controlled Phase III trials, VANISH-1 and VANISH-2, Varithena^™ achieved a clinically meaningful improvement in the symptoms of superficial venous incompetence and the appearance of visible varicosities and addressed the underlying venous incompetence in the majority of patients treated. Varithena^™ (polidocanol injectable foam) is a sclerosing agent indicated for the treatment of incompetent great saphenous veins, accessory saphenous veins, and visible varicosities of the great saphenous vein system above and below the knee.  Varithena^™ improves the symptoms of superficial venous incompetence and the appearance of visible varicosities.  Treatment is a minimally invasive, non-surgical procedure that requires neither tumescent anesthesia nor sedation.  Foam sclerotherapy has been used for years by medical doctors. What is new with Varithena^™, is that the foam is pre-made with low-nitrogen as opposed to room air, and is dispensed in a proprietary canister.   It is not yet available in doctor’s offices. Making Foam