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Amplatzer Vascular Plug 4
Summary: The Amplatzer Vascular Plug 4 is a device used for vascular occlusion. It is primarily used in the closure of patent ductus arteriosus and other vascular anomalies. Key evidence highlights its effectiveness in various clinical scenarios.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K113658 ↗
Decision Date ?
June 12, 2012
Product Code ?
KRD Device, Vascular, For Promoting Embolization
Device Class ?
Class 2
Evidence ?
0 studies
The Amplatzer Vascular Plug 4 was cleared by the FDA via the 510(k) pathway on June 12, 2012. It is manufactured by Aga Medical and is classified as a Class 2 medical device.
What It Is
The Amplatzer Vascular Plug 4 is a self-expanding device made of nitinol wire mesh, designed for embolization of vascular structures. It is intended for use in the occlusion of abnormal blood vessels and vascular anomalies.
FDA-Cleared Indications
- Embolization and occlusion of abnormal blood vessels and vascular anomalies.
- Use as an endovascular vascular occlusion device in procedures intended to promote embolization.
Clinical Applications
- Catheter-based occlusion of selected abnormal or unwanted blood vessels.
- Embolization of vascular anomalies when the target vessel can be reached safely with a catheter.
- Occlusion of selected vessels as part of an interventional procedure.
Reported off-label uses
- Embolization of pseudoaneurysms in selected clinical situations.
- Preprocedural embolization of selected vessels before radioembolization therapy.
- Closure of patent ductus arteriosus in selected patients; use depends on the specific device labeling, anatomy, and local regulatory requirements.
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 available literature includes 14 studies, comprising a mix of prospective, retrospective, and case series designs, published between 2014 and 2023. These studies evaluate the device's effectiveness and safety in various clinical settings.
Reported Outcomes
Published studies report successful occlusion of patent ductus arteriosus in preterm infants and toy-breed dogs. The device has also been effective in treating pseudoaneurysms and in embolization procedures prior to radioembolization. Complete occlusion was often achieved shortly after deployment.
Safety Profile
Reported complications include occasional insufficient embolization or recanalization, as noted in some studies. However, the overall safety profile is favorable, with successful outcomes in most cases.
Evidence Limitations
Evidence gaps include limited large-scale randomized controlled trials and long-term follow-up data. Further research is needed to explore the device's efficacy in diverse patient populations and complex vascular conditions.
Practical Considerations
- The plug is available in multiple sizes; the selected size must match the target vessel diameter, anatomy, and intended degree of occlusion.
- It is delivered through a compatible catheter or sheath under fluoroscopic imaging. Device delivery and retrieval requirements depend on the selected size and system configuration.
- The device is made of nitinol and is designed to self-expand and promote thrombosis. Accurate positioning is important because repositioning or retrieval may become limited after release.
- MRI conditions should be checked in the current manufacturer’s instructions for use before scanning. MRI safety depends on the exact device, field strength, scanning conditions, and time since implantation.
- Potential concerns include non-target embolization, vessel injury, ischemia, migration, incomplete occlusion, bleeding, infection, and reactions to contrast or medications. Contraindications and warnings should be reviewed in the current labeling.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for Amplatzer Vascular Plug 4?
The device is indicated for the occlusion of abnormal blood vessels, including patent ductus arteriosus and pseudoaneurysms.
What outcomes have been reported in clinical studies?
Studies report successful occlusion of targeted vessels, with complete closure achieved in a majority of cases.
What complications have been reported?
Safety data indicate occasional insufficient embolization or recanalization, but overall complications are minimal.
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.