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venovo venous stent system
Bard Peripheral Vascular
Summary: The Venovo Venous Stent System is a device used to treat symptomatic iliofemoral venous outflow obstruction. Key evidence highlights its use in various venous systems with some reported complications.
FDA Clearance Information
Pathway PMA
Number P180037 ↗
Decision Date March 13, 2019
Product Code QAN
Device Class Class 3
Evidence 3 studies
The Venovo Venous Stent System was cleared by the FDA via the PMA pathway on March 13, 2019. It is manufactured by Bard Peripheral Vascular and classified as a Class 3 device.
What It Is
The Venovo Venous Stent System is designed to treat symptomatic iliofemoral venous outflow obstruction. It is a self-expanding stent that provides support to the venous walls, facilitating improved blood flow.
Clinical Applications
The device is commonly used in patients with iliofemoral venous outflow obstruction, often due to conditions like deep vein thrombosis or chronic venous insufficiency. It is deployed endovascularly to restore venous patency.
Evidence Summary
The literature includes various study types such as RCTs, prospective, and retrospective studies, with a total of 6 studies ranging from 2018 to 2025. These studies explore the device's efficacy and safety in clinical settings.
Reported Outcomes
Published studies report that the Venovo Venous Stent System effectively restores venous patency in patients with iliofemoral venous outflow obstruction. Comparative studies highlight its performance against other stents, with some showing favorable outcomes in terms of complication rates and reintervention needs.
Safety Profile
Reported complications include embolization of the stent and issues related to device recall. Safety data from the MAUDE database highlights adverse events, emphasizing the need for careful patient selection and monitoring.
Evidence Limitations
The evidence is limited by the relatively small number of studies directly comparing the Venovo stent to other devices. Further research is needed to establish long-term outcomes and to explore its use in diverse patient populations.
Linked Studies (3)
PubMed • 2023
A practice audit of short-term outcomes of Wallstents versus Venovo stents for the treatment of nonthrombotic iliac vein outflow stenoses.
Journal of vascular surgery. Venous and lymphatic disorders
RCT|prospective|retrospective|case Series|other View Source → 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
BARD® The VENOVO™ Venous Stent Study for Treatment of Iliofemoral Occlusive Disease
View Source →Frequently Asked Questions
What are the clinical indications for Venovo Venous Stent System?
The device is indicated for the treatment of symptomatic iliofemoral venous outflow obstruction.
What outcomes have been reported in clinical studies?
Studies report effective restoration of venous patency and favorable outcomes compared to other stents in terms of complication rates.
What complications have been reported?
Safety data indicates complications such as stent embolization and issues related to device recall.
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.