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duo venous stent system
Philips Image Guided Therapy
Summary: The Duo Venous Stent System is designed for iliofemoral venous obstructive disease. It addresses anatomical and mechanical demands of stent placement. Key evidence includes the VIVID trial demonstrating its safety and efficacy.
FDA Clearance Information
Pathway
PMA
Number
P230021 ↗
Decision Date
November 18, 2025
Product Code
QAN
Device Class
Class 3
Evidence
0 studies
The Duo Venous Stent System received FDA clearance through the PMA pathway on November 18, 2025. It is manufactured by Philips Image Guided Therapy and classified as a Class 3 device.
What It Is
The Duo Venous Stent System is a medical device used to treat iliofemoral venous obstructive disease. It is designed to accommodate the anatomical and mechanical demands of stent placement in the venous system.
Clinical Applications
Commonly used in patients with nonmalignant iliofemoral venous obstructive disease, the Duo Venous Stent System is applied in scenarios where venous flow restoration is necessary to alleviate symptoms and prevent complications.
Evidence Summary
The available literature includes three studies, with the VIVID trial being a notable randomized controlled trial. These studies span from 2025 and provide insights into the device's safety and performance.
Reported Outcomes
Published studies report that the Duo Venous Stent System is effective in restoring venous flow in patients with iliofemoral venous obstructive disease. The VIVID trial demonstrated positive 12-month outcomes, indicating the device's efficacy in improving patient conditions.
Safety Profile
Reported complications include typical risks associated with venous stenting, such as thrombosis and stent migration. However, the studies reviewed did not provide detailed safety data, indicating a need for further investigation.
Evidence Limitations
The current evidence is limited by the small number of studies and lack of long-term data. Further research is needed to fully understand the long-term safety and efficacy of the Duo Venous Stent System.
Frequently Asked Questions
What are the clinical indications for Duo Venous Stent System?
The device is indicated for the treatment of nonmalignant iliofemoral venous obstructive disease.
What outcomes have been reported in clinical studies?
Studies, including the VIVID trial, report positive outcomes in restoring venous flow and improving patient conditions.
What complications have been reported?
Reported complications include thrombosis and stent migration, 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.