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merit siege vascular plug
Merit Medical System
Summary: The Merit Siege Vascular Plug is a medical device used to occlude vascular structures. It is primarily used by interventional radiologists and cardiologists for procedures requiring vascular embolization.
FDA Clearance Information
Pathway 510K
Number K212817 ↗
Decision Date December 15, 2021
Product Code KRD
Device Class Class 2
Evidence 0 studies
The Merit Siege Vascular Plug was cleared through the FDA 510(k) pathway on December 15, 2021. It is manufactured by Merit Medical System and is classified as a Class 2 device.
What It Is
The Merit Siege Vascular Plug is a device designed to occlude blood vessels. It is typically used in procedures where blood flow needs to be stopped or redirected, such as in the treatment of vascular malformations or to prevent blood flow to an area before surgery. The device is deployed via a catheter and expands to fill the vessel, creating a blockage.
Clinical Applications
This device is commonly used in interventional radiology and cardiology for procedures such as embolization of vascular malformations, closure of patent ductus arteriosus, or other congenital heart defects. It is suitable for use in both adult and pediatric populations, particularly in patients who are high-risk surgical candidates. The device is used in hospital settings, often in catheterization labs.
Indications for Use
The FDA-cleared indications for the Merit Siege Vascular Plug include occlusion of vascular structures in patients requiring embolization. It is intended for use in patients with conditions that necessitate the blockage of blood vessels, such as vascular malformations or certain congenital heart defects.
Practical Considerations
The device comes in various sizes to accommodate different vessel diameters. It is compatible with standard catheter systems used in vascular interventions. Clinicians should be familiar with catheter-based delivery techniques and consider the vessel size and flow dynamics when selecting the appropriate plug size.
Related Literature
The linked study explored the use of the Siege Vascular Plug for transcatheter closure of a residual mid-leaflet mitral valve cleft in a 19-year-old patient. The procedure was successful, demonstrating the device's potential in percutaneous mitral valve interventions. However, the study was limited to a single case, highlighting the need for further research to establish broader clinical efficacy and safety.
Frequently Asked Questions
What is the Merit Siege Vascular Plug used for?
The device is used for occluding blood vessels in procedures requiring embolization, such as treating vascular malformations or congenital heart defects.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use this device in vascular and cardiac procedures.
What are the FDA-cleared indications?
The device is indicated for the occlusion of vascular structures in patients requiring embolization, such as those with vascular malformations or congenital heart defects.
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.