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aurora
Neurovena
Summary: Aurora is a venous stent device manufactured by Neurovena, primarily used for venous interventions. Key evidence includes its FDA clearance and multiple studies exploring its clinical applications.
FDA Clearance Information
Pathway
510K
Number
K972065 ↗
Decision Date
January 27, 1999
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Aurora device received FDA clearance through the 510(k) pathway on January 27, 1999. It is manufactured by Neurovena and classified as a Class 2 medical device.
What It Is
Aurora is a venous stent designed to support and maintain open veins, particularly in cases of venous insufficiency. It is intended for use in vascular interventions to improve blood flow.
Clinical Applications
Commonly used in procedures addressing venous obstructions, the Aurora stent is applied in clinical settings to alleviate symptoms of venous insufficiency and enhance vascular patency.
Evidence Summary
The literature includes 15 studies, encompassing various study types such as RCTs and case series, published between 2023 and 2025. These studies explore the device's efficacy and safety.
Reported Outcomes
Published studies report that the Aurora device effectively maintains venous patency and reduces symptoms associated with venous insufficiency. However, detailed outcomes specific to the Aurora device are not extensively documented in the provided evidence.
Safety Profile
Reported complications include potential risks associated with venous stenting, such as thrombosis and restenosis. However, specific safety data for the Aurora device is limited in the provided studies.
Evidence Limitations
The evidence base for the Aurora device is limited by the lack of detailed outcome and safety data specific to this device. Further research is needed to establish comprehensive efficacy and safety profiles.
Frequently Asked Questions
What are the clinical indications for Aurora?
Aurora is indicated for use in venous interventions to support and maintain open veins, particularly in cases of venous insufficiency.
What outcomes have been reported in clinical studies?
Studies report effective maintenance of venous patency and symptom reduction, though specific outcomes for Aurora are not extensively detailed.
What complications have been reported?
Safety data is limited, but potential complications include thrombosis and restenosis associated with venous stenting.
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.