August 11, 2014First Varicose Vein Patient Treated with FDA-Approved Varithena® (polidocanol injectable foam) 1%
West Conshohocken, PA, 11 August 2014
Varithena® is now available in the US
BTG International Inc. announces that the first varicose vein patient has been treated with Varithena® (polidocanol injectable foam), the only FDA-approved foam for the treatment of incompetent great saphenous veins (GSV), accessory saphenous veins and visible varicosities of the GSV system both above and below the knee.
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 (HASTI™ symptoms).
Marlin Schul, M.D., M.B.A., of the Lafayette Regional Vein & Laser Center in Indiana, who conducted the first Varithena® procedure, said, “I am proud to now be able to offer Varithena® as a new treatment option for my patients with varicose veins. Varithena® is a convenient, minimally invasive treatment and patients can return to normal activities shortly after treatment.”
Paul McCubbin, Head of Varithena® at BTG, commented, “Varithena® is the first and only FDA-approved comprehensive treatment that improves the symptoms and appearance of varicose veins. We are delighted that this clinically proven product is now commercially available to qualified physicians.”
Varithena® is a uniform, low-nitrogen, polidocanol microfoam, dispensed from a proprietary canister device. 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.
Vein specialists practicing in the US who are interested in using Varithena® can connect with a BTG Territory Sales Manager by calling the Varithena Solutions Center™ at 855-971-VEIN (8346). To learn more about Varithena®, go to www.varithena.com.
BTG is a growing international specialist healthcare company that is developing and commercializing products targeting acute care, cancer and vascular diseases. The company has diversified revenues from sales of its own marketed products and from royalties on partnered products, and is seeking to acquire new programs and products to develop and market to specialist physicians. For further information about BTG, please visit our website at www.btgplc.com.
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.
Varithena® (polidocanol injectable foam) 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® improves symptoms related to or caused by varicose veins, and the appearance of varicose veins.
IMPORTANT SAFETY INFORMATION
You should not be treated with Varithena® if you are allergic to polidocanol or have clots in your blood vessels.
Severe allergic reactions have been reported in people treated with liquid forms of polidocanol and some patients have died from these reactions. Varithena® is a microfoam made from polidocanol. A healthcare professional will observe you for signs of allergic reactions for at least 10 minutes after you are treated with Varithena®.
Tell your doctor about all of your medical conditions, including if you
have arterial disease (a disease of the blood vessels)
have reduced mobility
have a history of blood clots in the veins or lungs
have had major surgery in the past 3 months
have recently had a long hospital stay
are pregnant or have recently been pregnant
The most common side effects seen with Varithena® are leg pain or discomfort, injection site bruising or pain, and potentially serious blood clots in the leg veins. These are not all of the possible side effects of Varithena®. Tell your healthcare provider about any side effect that bothers you or that does not go away. You can also report side effects to the FDA at 800-FDA-1088.
Varithena® is administered by your doctor. Doctors using Varithena® must be experienced in vein procedures and trained in using Varithena®.
See full Prescribing Information for Varithena® online at www.varithena.com.
Varithena, HASTI and Varithena Solutions Center are trademarks of Provensis Ltd., a BTG International group company. BTG and the BTG roundel logo are registered trademarks of BTG International Ltd.
For further information please contact:
Chris Sampson, Director of Corporate Communications
+44 (0) 20-7575-1595; Mobile: +44 (0) 7773-251178
Ashley Tapp, Communications Manager
+44 (0) 20-7575-1513; Mobile: +44 (0) 7790-811554
Rhonda L. Lipschutz, Account Supervisor
+1 215-446-8027; Mobile: +1 215-341-7975