Zilver Vena® Venous Self-Expanding Stent

Study suggests effective treatment of symptomatic iliofemoral venous outflow obstruction¹

The study, “Twelve-month end point results from the evaluation of the Zilver Vena venous stent in the treatment of symptomatic iliofemoral venous outflow obstruction (VIVO clinical study),” has shown that Zilver Vena is a safe and effective treatment option for patients diagnosed with symptomatic iliofemoral venous outflow obstruction.¹

The VIVO clinical trial was conducted between December 2013 and October 2016 and was published in the Journal of Vascular Surgery Venous and Lymphatic Disorders. The multicenter study enrolled 243 patients in the United States and Taiwan with symptomatic venous outflow obstruction of one iliofemoral venous segment. All participants received the Zilver Vena stent.¹

“One in three Americans over the age of 45 has some kind vein disease,”² according to the American Venous Forum. With chronic venous disease affecting 25 million adults in the United States,³ accessible treatment is crucial to maintaining quality of life for these patients, including those experiencing iliofemoral venous outflow obstruction.

Chronic venous outflow obstruction commonly refers to long-term stenotic and occlusive disease of the central veins or to iliofemoral outflow obstruction. Severe and chronic obstruction of the iliac veins can result in life-altering symptoms including chronic pain, while treatment options like anticoagulant therapy are not one-size-fits-all approaches to treating venous conditions.

The VIVO clinical study results showed that “the 30-day freedom from major adverse events rate was 96.7%, greater than the literature-defined performance goal of 87%.”¹ Similarly, “the 12-month primary quantitative patency rate was 89.9%, greater than the literature-defined performance goal of 76%.”¹

“The primary safety end point was 30-day freedom from major adverse events,”¹ and “the primary effectiveness end point was the 12-month rate of primary quantitative patency by venography as determined by the core laboratory.”¹

The study also found that the Zilver Vena stent led to clinical symptom improvement compared with the baseline. The change in the Venous Clinical Severity Score (VCSS) from baseline was -3.0 at one month and and -4.2 at 12 months, respectively.¹

The Zilver Vena stent has been approved by the US Food and Drug Administration (FDA) since October 9, 2020.

1. Hofmann L, Gagne P, Brown JA, et al.; VIVO study investigators. Twelve-month end point results from the evaluation of the Zilver Vena venous stent in the treatment of symptomatic iliofemoral venous outflow obstruction (VIVO clinical study). J Vasc Surg Venous Lymphat Disord. 2023;11(3):532–541.e4. doi: 10.1016/j.jvsv.2022.12.066.
2. What is vein disease and lymphedema? American Venous Forum Web site. https://www.venousforum.org/patients/what-is-vein-disease. Accessed on June 15, 2023.
3. Eberhardt RT, Raffetto JD. Chronic venous insufficiency. Circulation. 2014;130(4):333–346.

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