VANISH-1 and VANISH-2 clinical evidence
Two randomized multi-center controlled trials.
Varithena was evaluated in two pivotal trials—VANISH-1 and
VANISH-2—with the primary goal of improvement in varicose vein symptoms,
supported by its indications. Clinical trial efficacy also included improvement in
the appearance of varicose veins and physiological response to treatment.
VANISH-1 and VANISH-2 take-aways.1,2
Versatile. Efficient. Effective.
Varithena demonstrated clinically meaningful improvement in varicose vein symptoms and appearance, leading to its FDA approval.
Appearance
Symptom Relief
Retreatment
VANISH-2
VANISH-2 RCT studied 232 patients and showed only 3.4% of truncal veins required retreatment and 1 treatment is often all that’s needed to improve symptom and appearance of varicose veins.
VANISH-1
VANISH-1 RCT studied 279 patients and demonstrated significant and clinically meaningful improvement in both the symptoms and the appearance of varicose veins in patients with an incompetent GSV and/or accessory saphenous veins and visible varicosities.
References
- 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.
- Todd KL and Wright DI. Durability of treatment effect with polidocanol endovenous microfoam on varicose vein symptoms and appearance (VANISH-2). J Vasc Surg: Venous and Lym Dis. 2015; 3(3): 258-264.
Indications
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®
Varithena™ is a registered trademark of Boston Scientific. All other trademarks are property of their respective owners.
PI-1263705-AA