Varithena® Earns FDA Approval for 30 Day Post-Activation Shelf Life
Update provides physicians enhanced flexibility in aligning procedures to practice needs
West Conshohocken, PA, US: 6 July 2016: BTG plc (LSE:BTG), the specialist healthcare company, announced that the U.S. Food and Drug Administration 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 Dr. 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 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.
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BTG is a growing international specialist healthcare company bringing to market innovative products in specialist areas of medicine to better serve doctors and their patients. We have a portfolio of Interventional Medicine products to advance the treatment of liver tumors, severe blood clots, varicose veins and advanced emphysema, and Specialty Pharmaceuticals that help patients overexposed to certain medications or toxins. Inspired by patient and physician needs, BTG is investing to expand its portfolio to address some of today’s most complex healthcare challenges. To learn more about BTG, please visit: www.btgplc.com.
About Varithena® Varithena® (polidocanol injectable foam) 1% is a prescription medicine used to treat 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 symptoms of heaviness, achiness, swelling, throbbing, itching (HASTI® symptoms) related to or caused by varicose veins, and the appearance of varicose veins. Treatment is a nonsurgical procedure (no incision is required). Treatment usually takes less than one hour and patients may resume light activities as quickly as the same day of treatment. For further information, please visit www.varithena.com.Back to press releases