BTG plc, an international specialist healthcare company bringing announces that Health Canada has issued a Notice of Compliance approving Varithena (polidocanol injectable foam) for the treatment of incompetent great saphenous veins, accessory saphenous veins, and visible varicosities of the great saphenous vein (GSV) system, above and below the knee.
Varithena (polidocanol injectable foam) is a uniform, low-nitrogen, polidocanol microfoam, dispensed from a proprietary canister device. Treatment is minimally invasive, non-surgical (no incision) and requires neither tumescent anesthesia nor sedation.
Varithena is intended for use in adults with clinically significant venous reflux as diagnosed by duplex ultrasound and is indicated for the treatment of incompetent great saphenous veins, accessory saphenous veins, and visible varicosities of the GSV system, above and below the knee.
Varithena is intended for intravenous injection using ultrasound guidance, administered via a single cannula into the lumen of the target incompetent trunk veins or by direct injection into varicosities. Physicians administering Varithena must be experienced with venous procedures, possess a detailed working knowledge of the use of the duplex ultrasound in venous disease and be trained in the administration of Varithena. The use of Varithena is contraindicated in patients with known allergy to polidocanol and those with acute thromboembolic disease.
Warnings and precautions: Severe allergic reactions have been reported following administration of liquid polidocanol, including anaphylactic reactions, some of them fatal. Observe patients for at least 10 minutes following injection and be prepared to treat anaphylaxis appropriately.
Intra-arterial injection or extravasation of polidocanol can cause severe necrosis, ischemia or gangrene. Patients with underlying arterial disease, such as marked peripheral arteriosclerosis or thromboangiitis obliterans (Buerger’s Disease) may be at increased risk for tissue ischemia. If intra-arterial injection of polidocanol occurs, consult a vascular surgeon immediately.
Varithena can cause venous thrombosis. Follow administration instructions closely and monitor for signs of venous thrombosis after treatment. Patients with reduced mobility, history of deep vein thrombosis or pulmonary embolism, or recent (within 3 months) major surgery, prolonged hospitalization, or pregnancy are at increased risk for developing thrombosis.
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