Polidocanol injectable foam (Varithena, from BTG plc) gained FDA marketing clearance for the treatment of patients with incompetent veins and visible varicosities of the great saphenous vein (GSV) system. Varithena (formerly known as Varisolve PEM) is a pharmaceutical-grade, low-nitrogen, polidocanol foam dispensed from a proprietary 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.
Current treatments for varicose veins include thermal ablation and surgery. According to the company, Varithena provides US physicians with the only approved comprehensive therapy to improve symptoms and appearance for a wide range of varicose veins, including incompetent GSV, accessory saphenous veins and visible varicosities of the GSV system both above and below the knee. Treatment is a minimally invasive, non-surgical procedure that requires neither tumescent anesthesia nor sedation.
