(polidocanol injectable foam) 1%
Varithena (polidocanol) injectable foam is 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 improves the symptoms of superficial venous incompetence and the appearance of visible varicosities.
Features and Benefits Overview
VANISH-1 and VANISH-2 Clinical Trials
Varithena was evaluated in two randomized, blinded, multi-center clinical trials to asses the efficacy and safety for Varithena with the primary endpoint as improvement in varicose vein symptoms.* Clinical trial efficacy measures also included improvement in varicose vein appearance and physiological response to treatment.
- Data demonstrates efficacy and durability of Varithena treatment in the GSV
- To measure symptom relief, the VVSymQ® instrument was developed and thoroughly tested for reliability, sensitivity, and content validity, in accordance with FDA guidelines for the development of patient-reported outcomes (PRO) tools.2 It is the first and only varicose vein symptom PRO tool to meet these requirements.
- Using the VVSymQ® electronic daily diary, study patients rated the severity of the 5 most relevant varicose vein symptoms (HASTI™ Symptoms):
*Primary endpoint: Improvement in symptoms as measured by change in VVSymQ® Score from baseline to Week 8.
Varithena provided clinically meaningful improvement* in symptoms and appearance in patients with incompetent great saphenous veins (GSV), accessory saphenous veins, and visible varicosities of the GSV system. Improvement was measured by a patient global impression of change (PGIC) questionnaire at Week 8.
*Percent of patients who reported their symptoms (or appearance of varicose veins) had “moderately improved” or “much improved” compared with baseline.
Direct Order Contact Information
|BSC Direct||Physician Offices, Hospitals||855-971-8346 (VEIN)||VarithenaCustomerCare@bsci.com|
2 Todd KL III, Wright DI, and the VANISH-2 Investigator Group. The VANISH-2 study: a randomized, blinded, multicenter study to evaluate the efficacy and safety of polidocanol endovenous microfoam 0.5% and 1.0% compared with placebo for the treatment of saphenofemoral junction incompetence. Phlebology. 2014;29(9):608-618. doi:10.1177/0268355513497709.
3 Data on file. Provensis Ltd, 2013.