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FDA Approves Varicose Vein Treatment, Varithena
Injectable foam dissolves veins as alternative to surgery (November 26)
The FDA has approved Varithena (polidocanol injectable foam) 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 canister device. The product is designed to dissolve the veins as an alternative to surgical removal.
It took more than a decade for Varithena to win FDA approval, as the manufacturer (BTG) had to address concerns that the active agent in polidocanol could enter the bloodstream.
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 most of the patients treated.
More than 30 million adults (aged 18 to 70 years) in the U.S. have varicose veins, with women twice as likely as men to develop varicosities. Varicose veins often require treatment for symptoms, including leg pain, aching, heaviness, restless legs, cramps, throbbing, fatigue, itchiness, tingling, and edema.
Current treatments for varicose veins include thermal ablation and surgery. Varithena is the only approved 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. The treatment is a minimally invasive, nonsurgical procedure that requires neither tumescent anesthesia nor sedation.