FDA Approves 30-Day Postactivation Shelf Life for BTG's Varithena Venous Treatment

July 6, 2016—BTG International announced that the US Food and Drug Administration (FDA) has approved an extension of the postactivation shelf life of the company's Varithena (polidocanol injectable foam) 1%. The shelf life is extended from 7 days to 30 days.

According to the company, the update enhances the ease of scheduling for a comprehensive, above- and below-the-knee solution for great saphenous vein system incompetence and for veins that other procedures cannot reach effectively. Physicians can adapt the Varithena procedure to the unique demands of their practice, both in terms of timing of procedures and the wide range of vein sizes and shapes they can treat, including tortuous veins and visible varicosities.

In the company’s announcement, Brian Ferris, MD, commented, “Varithena has become an important part of my practice, in particular for patients with tortuous or difficult to treat veins, or for patients that do not want to undergo thermal ablation. With the FDA’s approval of a longer shelf life—once I have activated the canister—I have more flexibility in scheduling patients. This will help ensure that more patients who can benefit from Varithena will get the treatment.” Dr. Ferris is Chief of Surgery, Overlake Hospital Medical Center in Bellevue, Washington.

BTG stated that Varithena 1% is a prescription medicine used for the nonsurgical treatment of varicose veins caused by problems with the great saphenous vein (GSV) and other related veins in the leg's GSV system. Varithena helps improve the “HASTI” symptoms of heaviness, achiness, swelling, throbbing, and itching that are related to or caused by varicose veins and the appearance of varicose veins.