đź“Š Evidence-Based Reference
Zilver Vena Venous Self-Expanding Stent
Summary: The Zilver Vena Venous Self-Expanding Stent is used to improve luminal diameter in iliofemoral veins for symptomatic outflow obstruction. Key evidence highlights its effectiveness in treating venous obstructions.
FDA Clearance Information
Pathway ?
PMA
Number ?
P200023 ↗
Decision Date ?
October 9, 2020
Product Code ?
QAN Stent, Iliac Vein
Device Class ?
Class 3
Evidence ?
3 studies
The Zilver Vena Venous Self-Expanding Stent received FDA PMA clearance on October 9, 2020. Manufactured by Cook Ireland, it is classified as a Class 3 device.
What It Is
The Zilver Vena Venous Self-Expanding Stent is designed to expand within the iliofemoral veins, improving luminal diameter and alleviating symptoms of venous outflow obstruction. It is intended for use in patients with symptomatic iliofemoral venous obstruction.
FDA-Cleared Indications
- Improving luminal diameter in the iliofemoral veins.
- Treatment of symptomatic iliofemoral venous outflow obstruction.
Clinical Applications
- Endovascular treatment of symptomatic obstruction in the iliac or common femoral venous outflow pathway.
- Treatment of symptomatic iliofemoral venous obstruction after appropriate venous imaging and lesion assessment.
- Venous stenting performed to restore or improve flow through an obstructed iliofemoral venous segment.
Reported off-label uses
- Treatment of selected venous outflow lesions outside the specific labeled iliofemoral anatomy, when judged appropriate by a treating specialist.
- Use in some post-thrombotic venous obstruction patterns that extend beyond the precise labeled treatment segment.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
The literature includes a mix of retrospective and prospective studies, including RCTs, with a total of 7 studies published between 2021 and 2025. These studies evaluate the stent's performance in real-world and controlled settings.
Reported Outcomes
Published studies report that the Zilver Vena Stent effectively improves venous patency and alleviates symptoms associated with iliofemoral venous obstruction. Outcomes from real-world and clinical trials indicate positive long-term patency rates and symptom relief.
Safety Profile
Reported complications include typical risks associated with venous stenting, such as stent migration and thrombosis. However, the studies reviewed did not provide detailed safety data, indicating a need for further research.
Evidence Limitations
The current evidence is limited by the lack of comprehensive safety data and the need for longer-term follow-up studies. Further research is needed to fully understand the long-term safety and efficacy of the stent.
Practical Considerations
- The stent is self-expanding and must be sized and positioned according to the treated vein, lesion characteristics, and device instructions for use.
- Placement is typically performed through venous access, commonly in the femoral or jugular vein, using fluoroscopy and venography or intravascular ultrasound.
- The device should be evaluated for MRI compatibility under its current manufacturer labeling and the conditions specified for the implanted stent.
- Potential complications include stent migration, thrombosis, restenosis, bleeding at the access site, venous perforation, and recurrent symptoms.
- Contraindications and precautions include inability to receive the required antithrombotic treatment, active infection, unsuitable vessel anatomy, and uncorrectable bleeding risk; clinicians should follow the current instructions for use.
Procedures that use this device
Linked Studies (3)
PubMed • 2025
Real-world outcomes of Zilver Vena® Venous Self Expanding Stent placement for thrombotic and non-thrombotic indications in Spain.
Phlebology
View Source →PubMed • 2023
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).
Journal of vascular surgery. Venous and lymphatic disorders
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2021
One Year Outcomes of the VIVO-EU Study of Treatment of Symptomatic Iliofemoral Outflow Obstruction with the Zilver Vena Venous Self-Expanding Stent.
Cardiovascular and interventional radiology
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What are the clinical indications for Zilver Vena Venous Self-Expanding Stent?
The stent is indicated for improving luminal diameter in the iliofemoral veins for the treatment of symptomatic iliofemoral venous outflow obstruction.
What outcomes have been reported in clinical studies?
Studies report improved venous patency and symptom relief in patients with iliofemoral venous obstruction.
What complications have been reported?
Reported complications include stent migration and thrombosis, though detailed safety data is limited.
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.