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ventrax delivery system vtr851
Merit Medical Systems
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
510K
Number
K231246 ↗
Decision Date
August 30, 2023
Product Code
DQY
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.
Clinical Applications
This device is commonly used in clinical settings for the treatment of venous stenosis or occlusions. It is particularly relevant in procedures requiring precise stent placement in the venous system.
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.
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.