August 06, 2015
Health Canada approves Varithena™ (polidocanol injectable foam) for patients with varicose veins
London, UK, 06 August 2015
BTG plc (LSE: BTG), the specialist healthcare company, today announces that Health Canada has issued a Notice of Compliance approving Varithena™ (polidocanol injectable foam), a prescription medicine used to treat varicose veins. Varithena™ is indicated 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.1
Varithena™ improves symptoms related to or caused by varicose veins, and the appearance of varicose veins, and is proven to reduce the five symptoms patients consider most important – heaviness, achiness, swelling, throbbing, itching (known as HASTI™ symptoms).
Brad Pearson, Director of BTG Commercial Operations in Canada, said: “We’re proud to be offering physicians and patients in Canada a new, convenient, minimally invasive treatment for varicose veins. In clinical trials the majority of patients reported improvement in symptoms as well as improved vein appearance.”
Current treatments for varicose veins include thermal ablation and surgery. Varithena™ is a uniform, low-nitrogen, polidocanol microfoam, dispensed from a proprietary canister device. Treatment is a minimally invasive, non-surgical procedure (no incision) that usually takes less than one hour and requires neither tumescent anesthesia nor sedation. The physician injects a small amount of Varithena™ into the malfunctioning vein through a small tube (catheter) or a needle. It displaces the blood from the vein to reach and treat the vein wall; the diseased vein collapses and blood flow is diverted to healthy veins nearby.
BTG has established a wholly owned subsidiary, BTG International Canada Inc., to sell Varithena™ along with the company’s interventional oncology portfolio to specialist physicians in Canada.
Vein specialists practicing in Canada who are interested in using Varithena™ can learn more by contacting medical.services@btgplc.com.
About Varithena™
Varithena™ (polidocanol injectable foam) is a prescription medicine 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 use in adults with clinically significant venous reflux as diagnosed by duplex ultrasound.
The most common (>10%) adverse events in patients treated with Varithena™ include contusion, pain in extremity, headache and skin discoloration. See prescribing information for a full list of possible side effects.
Please consult the full Product Monograph for more information.
Photos illustrating the results of patients treated with Varithena™ are available on request. Individual treatment results may vary.
About Varicose Veins
An estimated 3.7 million Canadians have varicose veins, with women twice as likely as men to develop varicosities.2
Varicose veins are enlarged, bulging veins that most often occur in the leg's great saphenous vein (GSV) system. In health veins tiny valves help the leg veins work against gravity to push blood back to the heart. But if valves weaken, blood can leak backwards and pool, resulting in varicose veins. This can cause uncomfortable symptoms, such as heaviness, achiness, swelling, throbbing, and itching. These symptoms are frequently the cause of absenteeism from work, disability and decreased quality of life. Varicose veins often bulge above the surface of the skin, but they are not always visible. Common risk factors include family history, aging, being overweight or obese, and working at jobs requiring prolonged standing.
For further information contact:
BTG
Andy Burrows, VP Corporate & Investor Relations
+44 (0)20 7575 1741; Mobile: +44 (0)7990 530 605
Stuart Hunt, Investor Relations Manager
+44 (0)20 7575 1582; Mobile: +44 (0)7815 778 536
Chris Sampson, Corporate Communications Director
+44 20 7575 1595; Mobile: +44 7773 251 178
FTI Consulting
Ben Atwell/Simon Conway
+44 (0)20 3727 1000
About BTG
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 tumours, 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
References:
- Varithena™ Product Monograph. July 2015.
- Extrapolated to Canadian population from prevalence data in Gloviczki P, Comerota AJ, Dalsing MC, et al. The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg. 2011;53(5 suppl):2S-48S.