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Amplatzer Vascular Plug II Models AVP2-004 AVP2-006 AVP2-008 AVP2-010 AVP2-012 AVP2-014 AVP2-016
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 ?
510(k)
Number ?
K071125 ↗
Decision Date ?
June 18, 2007
Product Code ?
KRD Device, Vascular, For Promoting Embolization
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.
FDA-Cleared Indications
- Embolization of peripheral blood vessels when temporary or permanent vessel occlusion is clinically indicated.
- Treatment of abnormal blood flow, including selected vascular malformations, aneurysms, pseudoaneurysms, or bleeding vessels, when vessel occlusion is appropriate.
Clinical Applications
- Embolization of selected visceral or pelvic arteries and veins.
- Occlusion of a feeding vessel associated with an arteriovenous malformation or other abnormal vascular connection.
- Control of bleeding by embolizing an identifiable peripheral blood vessel.
- Treatment of selected aneurysms or pseudoaneurysms by blocking the inflow or outflow vessel.
Reported off-label uses
- Embolization of selected venous reflux pathways, including ovarian or gonadal veins, when clinically appropriate.
- Embolization of selected varicoceles.
- Occlusion of collateral vessels or other vascular channels not specifically described in the device labeling.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
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.
Practical Considerations
- Available models include nominal plug diameters of 4, 6, 8, 10, 12, 14, and 16 mm; sizing must account for the target vessel diameter, vessel shape, flow, and landing zone.
- The plug is delivered through a compatible catheter under fluoroscopic imaging. The required catheter size and delivery system depend on the specific model and instructions for use.
- Adequate stabilization and an appropriate landing zone are important because malposition, incomplete occlusion, or migration can occur, particularly in high-flow vessels.
- MRI safety and conditions depend on the current device labeling, field strength, specific model, and the complete implanted system; the current manufacturer MRI instructions should be reviewed before scanning.
- Contraindications and precautions include unsuitable vessel anatomy, active infection at the access or treatment site, inability to obtain safe vascular access, and situations in which vessel occlusion would cause unacceptable ischemia.
Procedures that use this device
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.