Varithena gets US FDA approval for 30 day post-activation shelf life


BTG has announced that the US FDA has approved an extension of the post-activation shelf life of Varithena (polidocanol injectable foam) 1% to thirty days, from seven.

“This approval provides physicians with greater flexibility,” said John Sylvester, corporate development officer for BTG. “It highlights our continued work to provide a non-thermal chemical ablation solution that best fits practices’ needs.”

“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,” said Brian Ferris, chief of Surgery, Overlake Hospital Medical Center. “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.”

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.

Varithena’s uniform density, size and stability formulation results in a long dwell time and thorough cohesion with the vein wall. It addresses underlying venous incompetence, improves vein appearance and shows significant improvements with an established safety profile. Tumescent anesthesia is avoided, and a cohesive, low-nitrogen microfoam allows for consistent performance, a press release from BTG says.