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Ottawa, Canada, 26 January 2017
The only Health Canada approved microfoam for the treatment of varicose veins is now available
BTG International Canada Inc., part of global specialist healthcare company BTG (LSE: BTG), today announced the Canadian commercial launch of Varithena™ (polidocanol injectable foam), a drug/device combination product used to treat varicose veins. Varithena™ is intended for use in adults with clinically significant venous reflux as diagnosed by duplex ultrasound.1
Varithena™ is indicated in Canada 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.
BTG International Canada Inc. has worked with vascular surgeons, phlebologists and vein treatment centres across the country to prepare and train physicians in the procedure since Varithena™ received its Health Canada approval.
Varithena™ is a uniform, low nitrogen, polidocanol microfoam dispensed from a proprietary canister device. A physician injects a small amount of Varithena™ into the malfunctioning vein of a patient 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 done a great job preparing the medical community with teaching materials and helpful protocol details," says Dr. Douglas Hill, MD, FCFP, FACPh, the principal of The Vein Treatment Centre in Calgary, Alberta, and president of the Canadian Society of Phlebology. "Varithena™ holds great promise to effectively treat varicose vein networks in just one visit and is able to treat large diameter GSVs that may not respond to other extemporaneous foam treatments".
3.7 Million Canadians with Varicose Veins2
An estimated 3.7 million Canadians have varicose veins, with women twice as likely as men to develop varicosities.
Varicose veins are enlarged, bulging veins that most often occur in the leg's GSV system. In healthy veins, tiny valves help the leg veins work against gravity to push blood back to the heart. Sometimes when valves weaken, blood can leak backwards and pool, resulting in varicose veins in the leg. This can cause uncomfortable symptoms, such as heaviness, achiness, swelling, throbbing, and itching in the leg. 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.
Clinics Across Canada Now Treating Patients
"Varithena™ is a new treatment option for my patients with torturous varicose veins who previously had unsuccessful large vein surgical procedures," states Dr. Theodore Rapanos, a principal at Oakville Vascular and associate professor and research director for the residency program, division of vascular surgery at McMaster University in Hamilton, Ontario. "We see the benefits to our patients as great. Varithena™ is convenient to administer and involves a minimally invasive treatment, with no incision, meaning patients can return to normal activities shortly after treatment". Oakville Vascular was the first centre in Canada to treat patients with Varithena™.
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 Commercial Operations at BTG International Canada Inc. concluded: "We are pleased to be offering Varithena™ to the Canadian market. Based on the response from qualified physicians from the vascular and phlebology communities across Canada, we believe Varithena™ will offer patients a new treatment option that is efficacious and patient friendly."
Varithena™ (polidocanol injectable foam) is indicated in Canada 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. 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 most common (>10%) adverse events in patients treated with Varithena™ include: contusion, pain in extremity, headache and skin discoloration. Varithena™ is contraindicated in patients with: a known allergy to polidocanol or any ingredient in the formulation; those with acute thromboembolic disease; those with thrombophilia; those who are pregnant.
Serious Warnings and Precautions
Allergic reaction: Varithena™ is a foam; one of the ingredients is polidocanol. Some people treated with polidocanol have had severe allergic reactions, and some of these people died. After you are treated with Varithena™, a healthcare professional will watch you for signs of an allergic reaction for at least 10 minutes.
Damage to skin and tissue: Varithena™ should only be injected into veins. If it is injected into arteries or outside of the vein it can cause permanent injury to the skin or tissue. If this happens, urgent care is required. The damage may be worse if you already have artery disease.
Blood clots – Deep vein thrombosis: Varithena™ can cause blood clots in the deep veins. Your healthcare professional will monitor you for signs of deep vein thrombosis, typically pain, swelling and blueness of the treated leg. If these symptoms develop after your treatment, see your doctor immediately. Patients with the following have an increased risk of having a blood clot: difficulty walking, obesity, history of blood clots in the deep veins of the leg or in the lung, surgery in the last 3 months, long stay in the hospital, cancer, taking oral birth control or hormone replacement therapy, or smoking.
Mini-strokes: Rarely, treatment of varicose veins has resulted in a mini-stroke (transient ischemic attack) or stroke. This has happened either minutes or days after treatment. These events have not been reported to date with Varithena™. Your doctor will be trained to manage the factors that may increase the risk of this happening. If you know you have a hole in your heart, called a patent foramen ovale (PFO; a common birth defect of the heart that usually causes no problem) you are at greater risk and you should tell your doctor so he can carefully consider if Varithena™ is right for you.
Please consult the full Prescribing Information or Product Monograph for more information about Varithena™.
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.
About BTG Interventional Medicine
BTG Interventional Medicine is part of BTG plc, a global specialist healthcare company. As medicine moves from major surgery to minor procedure, from the systemic to the local, no company endeavors to do more than BTG to help doctors in their quest to see more, reach further and treat smarter. Our growing portfolio of Interventional Medicine products is designed to advance the treatment of cancer, severe emphysema, severe blood clots, and varicose veins. To learn more about BTG Interventional Medicine, please visit: btg-im.com.
For further information contact:
Canadian Media Inquiries:
Eileen Tobey, beSPEAK Communications Inc.
+1416 540 4047
International Media Inquiries:
Chris Sampson, Director of Corporate Communications
+44 (0)20 7575 1595; Mobile: +44 (0)7773 251 178
Investor Relations Inquiries:
Andy Burrows, VP, Corporate & Investor Relations
+44 (0)20 7575 1741; Mobile: +44 (0)7990 530 605
1. Varithena™ Product Monograph. July 2015.
2. 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