FDA approves injectable foam for varicose veins

November 26, 2013

The Food and Drug Administration has approved Varithena (polidocanol injectable foam, BTG International) for the treatment of varicose veins.

 

The Food and Drug Administration has approved Varithena (polidocanol injectable foam, BTG International) for the treatment of varicose veins.

Varithena a sclerosing agent, was tested in two placebo-controlled phase III trials and demonstrated “clinically meaningful improvement” in symptoms of superficial venous incompetence and the appearance of varicose veins, according to a news release. The company states Varithena is the only approved comprehensive therapy for the symptoms and appearance of a range of varicose veins, such as accessory saphenous veins and incompetent great saphenous vein.

The treatment is minimally invasive and does not require sedation or tumescent anesthesia, according to the company. The foam is intended for intravenous injection using ultrasound guidance. The company notes that clinicians who administer the treatment should be experienced with venous procedures and possess a working knowledge of the use of duplex ultrasound in treating venous disease.

The product is expected to launch in the United States in the first quarter of 2014.