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vici venous stent system
Boston Scientific
Summary: The Vici Venous Stent System by Boston Scientific is used for treating chronic iliofemoral venous outflow obstruction. Key evidence includes a 3-year follow-up study showing its effectiveness.
FDA Clearance Information
Pathway PMA
Number P180013 ↗
Decision Date June 29, 2021
Product Code QAN
Device Class Class 3
Evidence 3 studies
The Vici Venous Stent System received FDA clearance through the PMA pathway on June 29, 2021. It is manufactured by Boston Scientific and classified as a Class 3 device.
What It Is
The Vici Venous Stent System is a self-expanding stent designed to treat venous obstructions, particularly in the iliofemoral veins. It is intended for use in patients with chronic venous outflow obstruction to restore proper blood flow.
Clinical Applications
Commonly used in cases of chronic iliofemoral venous outflow obstruction, the Vici Venous Stent System is applied in endovascular procedures to alleviate symptoms and improve venous circulation.
Evidence Summary
The available literature includes three studies, with types ranging from clinical trials to observational studies. The studies span from the initial premarket evaluation to ongoing follow-up research.
Reported Outcomes
Published studies report that the Vici Venous Stent System effectively manages chronic venous outflow obstruction, with significant improvements in venous patency and symptom relief. The VIRTUS study highlights its long-term efficacy over a 3-year period.
Safety Profile
Reported complications include potential risks associated with endovascular procedures, such as thrombosis and stent migration. However, specific safety data from the provided studies are limited.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of detailed safety outcomes. Further research is needed to confirm long-term safety and effectiveness in diverse patient populations.
Linked Studies (3)
PubMed • 2022
A Comparison of Patient and Device Issues Reported for Recalled Venous Stent Systems.
Annals of vascular surgery
RCT|prospective|retrospective|case Series|other View Source → ClinicalTrials.gov
VIRTUS: An Evaluation of the Vici™ Venous Stent System in Patients With Chronic Iliofemoral Venous Outflow Obstruction
View Source → ClinicalTrials.gov
Clinical Outcomes of IVUS-guided Stenting Using the Boston Scientific Vici® Venous Stent System in Treating Patients With Chronic Non-malignant Iliofemoral Vein Obstruction
View Source →Frequently Asked Questions
What are the clinical indications for Vici Venous Stent System?
The device is indicated for treating chronic iliofemoral venous outflow obstruction, as supported by the VIRTUS study results.
What outcomes have been reported in clinical studies?
Studies report improved venous patency and symptom relief in patients with chronic venous obstruction.
What complications have been reported?
Safety data from studies are limited, but potential complications include thrombosis and stent migration.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.