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VENITI VICI VENOUS STENT® System

CAUTION: INVESTIGATIONAL DEVICE. Limited by United States law to investigational use.

Chronic venous disorders (CVD) have a significant social and economic cost, impacting an estimated 50% of the population, and consuming an estimated 2-3% of healthcare budgets.1

It is well understood in the physician community that percutaneous stenting of the iliofemoral venous outflow can be performed with low morbidity, low mortality, long-term high patency rate, and low rate of in-stent restenosis.2,3,4,5 Clinical outcomes have demonstrated significant improvement in pain, swelling, and ulcer healing, substantial decrease of venous severity and disability scores and improved quality of life2,4,5,6,7, It has replaced bypass surgery as the primary treatment of venous outflow obstruction.

The VIRTUS study is being performed under a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE). VIRTUS is a prospective, multicenter, single arm, non-randomized study that will include 200 patients, at a maximum of 30 investigational sites worldwide.

If you are interested in learning more about this study, please refer to the clinicaltrials.gov website: http://clinicaltrials.gov/ct2/show/NCT02112877?term=veniti&rank=1

ClinicalTrials.gov Identifier: NCT02112877

CMS Category: B2

 

 

References

  1. Eklof B, Perrin M, Delis K, Rutherford R, P G. Updated terminology of chronic venous disorders: the VEIN-TERM transatlantic interdisciplinary consensus document. J Vasc Surg. 2009;49(2):498-501.
  2. Hartung O, Otero A, Boufi M, al e. Mid-term result of endovascular treatment for symptomatic chronic nonmalignant iliocaval venous occlusive disease. J Vasc Surg. 2005;42:1138-44.
  3. Neglén P, Hollis K, Olivier J, Raju S. Stenting of the venous outflow in chronic venous disease: long-term stent-related outcome, clinical, and hemodynamic result. J Vasc Surg. 2007;46:979-90.
  4. Kölbel T, Lindh M, Akesson M, Wassèlius J, A G, Ivancev K. Chronic iliac vein occlusion: midterm results of endovascular recanalization. J Endovasc Ther. Aug 2009;16(4):483-91.
  5. Meng Q, Li X, Qian A, Sang H, Rong J, Zhu L. Endovascular treatment of iliac vein compression syndrome. Chinese Medical Journal. 2011;124(20):3281-3284.
  6. Rosales A, Slagsvold C, Jørgensen J, Sandbaek G. Surgical Treatment of chronic venous insufficiency. Tidsskr Nor Laegeforen. 2009;129(22):2378-80.
  7. Wahlgren C, Wahlberg E, Olofsson P. Endovascular treatment in postthrombotic syndrome. Vasc Endovascular Surg. 2010;44(5):356-60.