đź“Š Evidence-Based Reference
amplatzer vascular plug ii models avp2-003 avp2-018 avp2-020 avp2-022
Aga Medical
Summary: The Amplatzer Vascular Plug II is a device used for embolization in vascular procedures. It is primarily used to occlude abnormal blood vessels. Key evidence highlights its precise deployment and high resistance to migration.
FDA Clearance Information
Pathway 510K
Number K071699 ↗
Decision Date August 15, 2007
Product Code KRD
Device Class Class 2
Evidence 0 studies
The Amplatzer Vascular Plug II, manufactured by Aga Medical, was cleared by the FDA through the 510(k) pathway on August 15, 2007. It is classified as a Class 2 medical device.
What It Is
The Amplatzer Vascular Plug II is a vascular occlusion device designed to embolize blood vessels. It is used in interventional radiology to achieve hemostasis by occluding abnormal vessels or vascular malformations.
Clinical Applications
Common clinical scenarios for the Amplatzer Vascular Plug II include embolization of vessels with irregular lumens and closure of portosystemic shunts. It is often utilized in cases where precise positioning and high migration resistance are required.
Evidence Summary
The literature includes 9 studies, comprising case reports and experimental models, published between 2021 and 2024. These studies explore various applications and techniques involving the Amplatzer Vascular Plug II.
Reported Outcomes
Published studies report that the Amplatzer Vascular Plug II enables precise positioning and high resistance to migration, making it effective for embolization in short segments. The coil-in-plug technique has been developed to enhance embolization efficacy in larger vessels.
Safety Profile
Reported complications include the risk of recanalization when the device is used in vessels with irregular lumens. The coil packing technique between the plug lobes has been suggested to mitigate this risk.
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 abnormal blood vessels, including those with irregular lumens and portosystemic shunts.
What outcomes have been reported in clinical studies?
Studies report effective embolization with precise positioning and high resistance to migration, particularly when using the coil-in-plug technique.
What complications have been reported?
Safety data indicate a risk of recanalization in vessels with irregular lumens, which may be mitigated by the coil packing technique.
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.