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amplatzer vascular plug 4
Aga Medical
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 510K
Number K113658 ↗
Decision Date June 12, 2012
Product Code KRD
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.
Clinical Applications
Common clinical scenarios for the Amplatzer Vascular Plug 4 include the closure of patent ductus arteriosus in both human and veterinary patients, and the treatment of pseudoaneurysms. It is also used in embolization procedures prior to radioembolization therapy.
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.
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.