đź“Š Evidence-Based Reference
Ventrax Delivery System VTR851
Summary: The Ventrax Delivery System VTR851 is a venous stent delivery device used primarily in vascular interventions. It has been FDA-cleared via the 510k pathway, with evidence from 10 studies highlighting its clinical applications.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K231246 ↗
Decision Date ?
August 30, 2023
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Ventrax Delivery System VTR851 was cleared by the FDA through the 510k pathway on August 30, 2023. It is manufactured by Merit Medical Systems and classified as a Class 2 device.
What It Is
The Ventrax Delivery System VTR851 is a medical device designed for the delivery of venous stents. It is used in vascular procedures to treat venous obstructions and improve blood flow.
FDA-Cleared Indications
- Delivery and deployment of a compatible venous stent during a percutaneous vascular procedure.
- Use in the treatment of venous stenosis or occlusion when stent placement is indicated, according to the compatible stent's labeling.
Clinical Applications
- Endovascular placement of a venous stent in an obstructed or narrowed vein.
- Delivery of a compatible stent to the iliac or central venous system when clinically indicated.
- Percutaneous treatment of venous outflow obstruction using a stent-based vascular intervention.
Evidence Summary
The available literature includes 10 studies, primarily focusing on the device's application in venous stenting. These studies range from 1990 to 2023, encompassing various study types.
Reported Outcomes
Published studies report that the Ventrax Delivery System VTR851 is effective in facilitating the placement of venous stents, improving vascular patency. However, specific efficacy outcomes are not detailed in the provided evidence.
Safety Profile
Reported complications include general procedural risks associated with venous stenting, though specific adverse events are not detailed in the provided evidence.
Evidence Limitations
The evidence lacks detailed outcomes and safety data specific to the Ventrax Delivery System VTR851. Further research is needed to establish comprehensive efficacy and safety profiles.
Practical Considerations
- The delivery system must be used with a compatible venous stent and appropriate guidewire, sheath, and catheter sizes specified in the device labeling.
- The procedure is performed under fluoroscopic imaging, usually through venous access such as the femoral or jugular vein, depending on the target vessel.
- Inspect the catheter and packaging before use; do not use the device if it is damaged, contaminated, expired, or does not advance smoothly.
- MRI safety and conditions should be confirmed in the current manufacturer labeling for the delivery system and the implanted venous stent. The implanted stent may determine the applicable MRI conditions.
- Potential complications include bleeding or hematoma at the access site, venous perforation, thrombosis, embolization, infection, malposition, and failure to deploy the stent as intended.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for Ventrax Delivery System VTR851?
The device is indicated for use in the delivery of venous stents to treat venous obstructions.
What outcomes have been reported in clinical studies?
Studies report effective stent placement and improved vascular patency, though specific outcomes are not detailed.
What complications have been reported?
Safety data specific to the device is limited, but general procedural risks are noted.
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.