Varithena clinical trials.
The data all adds up.
VANISH-1 and VANISH-2
Two randomized, multi-center controlled trials demonstrated efficacy and durability of Varithena treatment in the GSV and led to FDA approval.
Percentage of patients reporting
clinically meaningful improvement
Clinically meaningful improvement in symptoms.1
Improvement in symptoms is measured by change in VVSymQ® Score from baseline to Week 8. At Week 8, VVSymQ* scores for patients being treated with Varithena (polidocanol injectable foam) 1% had decreased significantly from baseline.
in appearance of varicose veins
Significantly superior improvement in appearance.2
Improvement in appearance is measured by change in IPR-V3 (independent photography review of visible varicose veins) rating from baseline to Week 8. By Week 8, physicians found meaningful improvement in appearance of varicose veins.
*VVSymQ: a patient-reported outcome instrument developed in accordance with FDA guidance. Patients rated daily duration of 5 varicose vein symptoms: heaviness, achiness, swelling, throbbing.
Varithena’s record of safety and efficacy isn’t limited to clinical studies. The key findings below are from a collection of real-world studies and peer-reviewed journals. Click the link to view more in-depth summaries.
Dr. Carugo's 2016 study
Varithena polidocanol endovenous microfoam was shown to be generally more stable and durable than physician compounded foams.3
Dr. Deak's 2021 study
Varithena was shown to be comparable in safety and efficacy to endovenous laser ablation (EVLA) with elimination of reflux in 93.5% and 92.8% of Varithena and EVLA-treated patients, respectively.4
Dr. Vasquez's 2017 study
Fewer patients required retreatment if they were treated with both endovenous thermal ablation (ETA) and Varithena, rather than solely ETA.5
Dr. Deak’s 2018 study
A retrospective patient chart review showed complete elimination of venous valvular reflux and vein closure in 94.4% of patients. 6
Before & after treatment
These photos show results after one treatment with Varithena. Additional treatments may be needed, depending on the number and size of veins to be treated.
* All images compare foams within approximately 10 seconds of creation. Photos of physician-compounded foam feature examples of manually created foam made 1:4 with 1% polidocanol solution and room air, Tessari technique. Because of varying conditions and techniques, properties of physician-compounded foams may vary. Photos by RSSL (Reading Scientific Services Ltd, UK).
Hear from your peers. Read case study summaries* that detail
treatment processes and outcomes and explain why physicians
chose Varithena to treat patients’ varicose veins.
* Results from case studies are not necessarily predictive of results in other cases. Results in other cases may vary.
- King JT, O’Byrne M, Vasquez M, Wright D; VANISH-1 Investigator Group. Treatment of Truncal Incompetence and Varicose Veins with a Single Administration of a New Polidocanol Endovenous Microfoam Preparation Improves Symptoms and Appearance. Eur J Vasc Endovasc Surg. 2015 Dec;50(6):784-93. doi: 10.1016/j.ejvs.2015.06.111. Epub 2015 Sep 16. PMID: 26384639.
- 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.
- Carugo D, Ankrett DN, Zhao X, et al. Phlebology: May 2016; 31(4):283-95.
- Deak ST. Treatment of superficial venous insufficiency in a large patient cohort with retrograde administration of ultrasound-guided polidocanol endovenous microfoam versus endovenous laser ablation. J Vasc Surg Venous Lymphat Disord. 2021 Dec 24:S2213-333X(21)00609-0. doi: 10.1016/j.jvsv.2021.11.007. Epub ahead of print. PMID: 34958977.
- Vasquez, Michael. “A multicenter, randomized, placebo-controlled trial of endovenous thermal ablation with or without polidocanol endovenous microfoamtreatment in patients with great saphenous vein incompetence and visible varicosities.” Phlebology.2017 May;32(4):272-281. doi: 10.1177/0268355516637300. The author is a consultant for Boston Scientific.
- Deak, Steven T. “Retrograde Administration of Ultrasound-Guided Endovenous Microfoam Chemical Ablation for the Treatment of Superficial Venous Insufficiency.” Journal of Vascular Surgery: Venous and Lymphatic Disorders, vol. 6, no. 4, July 2018, pp. 477–484., doi:https://doi.org/10.1016/j.jvsv.2018.03.015. The author is a consultant for Boston Scientific.
Varithena® (polidocanol injectable foam) 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. Varithena® improves the symptoms of superficial venous incompetence and the appearance of visible varicosities.
Important Safety Information
The use of Varithena® is contraindicated in patients with known allergy to polidocanol and those with acute thromboembolic disease. 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 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. The most common adverse events observed were pain/discomfort in extremity, retained coagulum, injection site hematoma or pain, common femoral vein thrombus extension, superficial thrombophlebitis, and deep vein thrombosis. 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®.
See Full Prescribing Information for Varithena®