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Amplatzer Vascular Plug
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 ?
510(k)
Number ?
K031810 ↗
Decision Date ?
September 9, 2003
Product Code ?
KRD Device, Vascular, For Promoting Embolization
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.
FDA-Cleared Indications
- Occlusion of abnormal vascular connections.
- Vascular embolization to promote controlled vessel occlusion.
- Prevention or treatment of endoleaks associated with endovascular aneurysm repair when embolization is clinically indicated.
Clinical Applications
- Occlusion of selected arteriovenous fistulas or other abnormal vascular communications.
- Embolization of vessels associated with endoleaks after endovascular aneurysm repair.
- Controlled occlusion of a target artery or vein during an endovascular procedure.
- Treatment of abnormal vascular connections in elective or urgent clinical settings when catheter-directed embolization is appropriate.
Reported off-label uses
- Embolization of selected visceral arteries, such as the splenic artery, for aneurysm, pseudoaneurysm, trauma, or hypersplenism.
- Embolization of gonadal or pelvic veins in selected patients with varicocele or pelvic venous congestion.
- Proximal occlusion of selected internal iliac artery branches during pelvic or aneurysm procedures.
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 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.
Practical Considerations
- The plug is delivered through a compatible catheter; the required catheter size depends on the specific plug model and diameter selected.
- Accurate angiography is needed to measure the target vessel, confirm blood-flow direction, and select an appropriately oversized device when required by the device instructions for use.
- The device is intended for permanent vascular occlusion. Repositioning or retrieval may be possible before release for some models, but this depends on the device and delivery system.
- MRI safety depends on the specific Amplatzer Vascular Plug model and its labeling. The exact model should be confirmed before an MRI examination.
- Contraindications and precautions include unsuitable vessel anatomy, inability to safely access the target vessel, active infection at the treatment site, and intolerance to the procedure or contrast material.
Procedures that use this device
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.