📊 Evidence-Based Reference
Ventrax Delivery System
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Summary: The Ventrax Delivery System is a venous stent delivery device used in vascular interventions. It is primarily used for the placement of venous stents to treat venous obstructions. Key evidence findings are limited due to the lack of specific study outcomes.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K202610 ↗
Decision Date ?
December 14, 2020
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Ventrax Delivery System was cleared by the FDA through the 510(k) pathway on December 14, 2020. It is manufactured by Merit Medical Systems and classified as a Class 2 device.
What It Is
The Ventrax Delivery System is designed for the delivery and placement of venous stents. It is used in clinical settings to treat venous obstructions by facilitating the deployment of stents within the venous system.
FDA-Cleared Indications
- Used to facilitate the delivery and placement of compatible venous stents within the venous system.
- Used during endovascular treatment of venous obstruction when placement of a venous stent is indicated.
Clinical Applications
- Delivery and deployment of venous stents in the iliac veins.
- Delivery and deployment of venous stents in central veins.
- Endovascular treatment of venous obstruction requiring stent placement.
- Use during venous-stenting procedures to position a stent at the intended treatment site.
Evidence Summary
The available literature includes 10 studies, though specific outcomes and safety data are not detailed. The studies range from 2017 to 2023, but none directly address the Ventrax Delivery System.
Reported Outcomes
Published studies report no specific efficacy findings related to the Ventrax Delivery System due to the absence of targeted research within the provided evidence.
Safety Profile
Reported complications include a lack of specific safety data for the Ventrax Delivery System, as the evidence provided does not directly address this device.
Evidence Limitations
The evidence lacks direct studies on the Ventrax Delivery System, highlighting a gap in specific efficacy and safety data. Further research is needed to establish comprehensive clinical outcomes and safety profiles.
Practical Considerations
- The delivery system must be matched to the specific venous stent, vessel size, access route and procedural anatomy.
- Use requires fluoroscopic or other appropriate imaging guidance and standard endovascular access equipment.
- The device is intended for use by trained clinicians familiar with venous intervention and stent deployment.
- MRI safety depends on the implanted venous stent and its labeling; the delivery catheter is removed after the procedure. Do not assume MRI compatibility without checking the stent's instructions for use.
- Risks are related to catheterization, venous stenting and the underlying condition and may include bleeding, infection, vessel injury, thrombosis, stent migration or recurrent obstruction.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for Ventrax Delivery System?
The Ventrax Delivery System is indicated for the delivery and placement of venous stents in cases of venous obstructions.
What outcomes have been reported in clinical studies?
Specific outcomes related to the Ventrax Delivery System have not been reported in the provided evidence.
What complications have been reported?
Safety data specific to the Ventrax Delivery System is not available in the provided evidence.
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.