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amplatzer vascular plug
Aga Medical
Summary: The Amplatzer Vascular Plug is a device used for vascular occlusion in endovascular procedures. It is primarily used to prevent endoleaks and close abnormal vascular connections. Key evidence highlights its efficacy in various vascular conditions.
FDA Clearance Information
Pathway
510K
Number
K031810 ↗
Decision Date
September 9, 2003
Product Code
KRD
Device Class
Class 2
Evidence
0 studies
The Amplatzer Vascular Plug was cleared by the FDA through the 510(k) pathway on September 9, 2003. It is manufactured by Aga Medical and classified as a Class 2 device.
What It Is
The Amplatzer Vascular Plug is a vascular occlusion device designed to provide controlled embolization in endovascular procedures. It is intended for use in the occlusion of abnormal vascular connections and prevention of endoleaks.
Clinical Applications
Common clinical scenarios for the Amplatzer Vascular Plug include the closure of arteriovenous fistulas, prevention of endoleaks during aneurysm repair, and occlusion of abnormal vascular communications. It is used in both elective and emergency settings.
Evidence Summary
The literature includes 15 studies, comprising case reports, systematic reviews, and other study types, published between 2022 and 2024. These studies explore the device's efficacy and safety in various vascular applications.
Reported Outcomes
Published studies report that the Amplatzer Vascular Plug is effective in occluding abnormal vascular connections and preventing endoleaks. It has been successfully used in treating arteriovenous fistulas and other vascular anomalies, demonstrating favorable outcomes in endovascular procedures.
Safety Profile
Reported complications include the potential for device migration and incomplete occlusion. However, the studies generally indicate a low incidence of adverse events, with the device being well-tolerated in most cases.
Evidence Limitations
The evidence is limited by the small sample sizes and the predominance of case reports and retrospective studies. Further research with larger, randomized controlled trials is needed to better establish the device's long-term efficacy and safety profile.
Frequently Asked Questions
What are the clinical indications for Amplatzer Vascular Plug?
The device is indicated for the occlusion of abnormal vascular connections, such as arteriovenous fistulas, and prevention of endoleaks during aneurysm repair.
What outcomes have been reported in clinical studies?
Studies have reported successful occlusion of vascular anomalies and prevention of endoleaks, with favorable procedural outcomes.
What complications have been reported?
Safety data indicate potential complications such as device migration and incomplete occlusion, though these are relatively uncommon.
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.