Varithena earns FDA approval for 30-day post-activation shelf life


first-varicose-vein-patient-treated-with-fda-approved-varithena-polidocanol-injectable-foam-1BTG has announced that the US Food and Drug Administration (FDA) has approved an extension of the post-activation shelf life of Varithena (polidocanol injectable foam) 1% to 30 days from seven. The announcement was made on 6 July 2016.

“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, Bellevue, USA. “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 UDSS formulation with uniform density, size and stability 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.