Varithena™

(polidocanol injectable foam) 1%

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Varithena Mechanism of Action
Varithena Canister with Varithena Transfer Unit
Varithena Administration Kit Contents
Varithena Mechanism of Action
Varithena Canister with Varithena Transfer Unit
Varithena Administration Kit Contents

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.

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Product Description

Features and Benefits Overview

Varithena is a non-thermal, non-tumescent treatment for the great saphenous vein system (GSV) and associated veins of the GSV system, and is the only FDA approved foam indicated for treating venous insufficiency. Varithena’s patented Microfoam UDSS™ technology produces cohesive, low-nitrogen microfoam1 with O2:CO2 (65:35) gas mixture with <0.8% nitrogen. The cohesive microfoam fills the lumen for circumferential contact1 where it’s designed to displace blood and destroy the endothelial lining efficiently. Varithena uses no tumescent anesthesia and takes about 10 minutes to administer.

Clinical Trials

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):
    • Heaviness
    • Achiness
    • Swelling
    • Throbbing
    • Itching

*Primary endpoint: Improvement in symptoms as measured by change in VVSymQ® Score from baseline to Week 8.

Conclusion

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.

Ordering Information

Varithena can be ordered directly through Boston Scientific or another approved specialty distributor. A new Varithena administration pack is needed to each patient. It is recommended you have an additional Varithena bi-cannister and administration pack on hand at all times.  

Direct Order Contact Information

Distributor Customer Telephone Web Orders
BSC Direct Physician Offices, Hospitals 855-971-8346 (VEIN) VarithenaCustomerCare@bsci.com

References

1 Eckmann DM. Polidocanol for endovenous microfoam sclerosant therapy. Expert Opin Investig Drugs. 2009;18(12):1919-1927.
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.
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