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Amplatzer Vascular Plug II Models AVP2-003 AVP2-018 AVP2-020 AVP2-022
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 ?
510(k)
Number ?
K071699 ↗
Decision Date ?
August 15, 2007
Product Code ?
KRD Device, Vascular, For Promoting Embolization
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.
FDA-Cleared Indications
- Embolization of peripheral blood vessels.
- Occlusion of abnormal or unwanted blood flow in selected vessels.
- Use in vessels where controlled deployment and resistance to migration are clinically important.
Clinical Applications
- Embolization of peripheral vessels with abnormal blood flow.
- Occlusion of vessels supplying vascular malformations.
- Closure of selected portosystemic shunts when the anatomy and vessel size are suitable.
- Embolization of irregular or short vascular segments when a detachable plug is appropriate.
Reported off-label uses
- Embolization of selected visceral artery aneurysms or pseudoaneurysms.
- Internal iliac artery branch embolization before or during treatment of an iliac artery aneurysm.
- Ovarian or gonadal vein embolization for pelvic venous disorders or varicocele.
- Embolization of selected splenic artery branches or the proximal splenic artery.
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 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.
Practical Considerations
- Available models in this record include AVP2-003, AVP2-018, AVP2-020 and AVP2-022; the correct plug size depends on the target vessel diameter, landing zone and desired degree of occlusion.
- The device is delivered through a compatible catheter under fluoroscopic imaging. The catheter and delivery system must be compatible with the selected plug size and the planned access route.
- Adequate landing length and stable vessel walls are important because deployment in a vessel that is too small, too large, highly tortuous or unsuitable may increase the risk of migration or incomplete occlusion.
- The plug is a permanent implant unless it is retrieved during the procedure before final release. Recanalization, non-target embolization, vessel injury and incomplete occlusion are possible complications.
- MRI conditions should be checked in the current manufacturer labeling and institutional device-reference system before scanning. Patients should tell MRI staff that they have an implanted vascular occlusion device.
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 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.