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amplatzer vascular plug ii models avp2-004 avp2-006 avp2-008 avp2-010 avp2-012 avp2-014 avp2-016
Aga Medical
Summary: The Amplatzer Vascular Plug II is a device used for embolization of blood vessels. It is primarily used in vascular interventions to occlude abnormal blood flow. Key evidence highlights its precision and resistance to migration.
FDA Clearance Information
Pathway
510K
Number
K071125 ↗
Decision Date
June 18, 2007
Product Code
KRD
Device Class
Class 2
Evidence
0 studies
The Amplatzer Vascular Plug II was cleared by the FDA through the 510(k) pathway on June 18, 2007. It is manufactured by Aga Medical and is classified as a Class 2 medical device.
What It Is
The Amplatzer Vascular Plug II is a self-expanding device designed to occlude blood vessels. It is used in interventional radiology to block abnormal blood flow, leveraging its precise deployment and high resistance to migration.
Clinical Applications
Commonly used in scenarios requiring vessel embolization, such as treating arteriovenous malformations or controlling bleeding. It is particularly useful in vessels with irregular lumens due to its design.
Evidence Summary
The literature includes 9 studies, comprising a mix of case reports and experimental studies, published between 2021 and 2024. These studies explore various clinical applications and techniques involving the device.
Reported Outcomes
Published studies report that the Amplatzer Vascular Plug II provides effective embolization with high precision and resistance to migration. The coil-in-plug technique has been shown to enhance embolization in certain cases. However, there are instances of inadequate embolization or recanalization, particularly in vessels with irregular lumens.
Safety Profile
Reported complications include the potential for inadequate embolization or recanalization, especially in vessels with irregular lumens. No specific adverse events were detailed in the provided studies.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of large-scale randomized controlled trials. Further research is needed to explore long-term outcomes and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Amplatzer Vascular Plug II?
The device is indicated for embolization of blood vessels, particularly in cases of arteriovenous malformations and other vascular abnormalities.
What outcomes have been reported in clinical studies?
Studies report effective embolization with high precision and resistance to migration, though some cases of inadequate embolization have been noted.
What complications have been reported?
Safety data indicate potential for inadequate embolization or recanalization, especially in vessels with irregular lumens.
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.