BTG has announced that the FDA has approved polidocanol injectable foam (Varithena) for the treatment of patients with incompetent veins and visible varicosities of the great saphenous vein 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.
Varithena is indicated for a wide range of varicose veins, including incompetent great saphenous vein, accessory saphenous veins and visible varicosities of the great saphenous vein system both above and below the knee. The treatment is a minimally invasive, non-surgical procedure that requires neither tumescent anaesthesia nor sedation.
Louise Makin, CEO at BTG, said: “We are delighted to receive US approval for Varithena, which we believe sets a new standard for the treatment of both the symptoms and appearance of varicose veins. We look forward to the commercial US launch in the second quarter of 2014, and to continuing to advance our plans to expand use into other geographies and into non-symptomatic veins.”