Two randomized multicenter 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 one treatment is often all that’s needed to improve symptoms 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.