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Medusa Vascular Plug
Summary: The Medusa Vascular Plug is a medical device used to occlude blood vessels. It is typically used by interventional radiologists and vascular surgeons to manage vascular abnormalities or bleeding.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K140796 ↗
Decision Date ?
December 2, 2014
Product Code ?
KRD Device, Vascular, For Promoting Embolization
Device Class ?
Class 2
Evidence ?
0 studies
The Medusa Vascular Plug was cleared through the FDA 510(k) pathway on December 2, 2014. It is manufactured by Endoshape and classified as a Class 2 device.
What It Is
The Medusa Vascular Plug is a device designed to occlude or block blood vessels. It is made from a flexible, shape-memory material that allows it to conform to the vessel's anatomy. This plug is deployed via catheter, expanding to fit the vessel and effectively stopping blood flow to a targeted area.
FDA-Cleared Indications
- Occlusion of peripheral blood vessels.
- Promotion of embolization in a targeted peripheral vessel.
Clinical Applications
- Catheter-based occlusion of selected peripheral arteries or veins.
- Embolization of peripheral vessels associated with vascular malformations.
- Control of blood flow from a targeted peripheral vessel during management of hemorrhage.
- Planned vessel occlusion during selected peripheral vascular procedures.
Practical Considerations
- The plug is available in different sizes; selection depends on the target vessel diameter, anatomy and desired degree of occlusion.
- It is delivered through a compatible catheter under fluoroscopic or other appropriate imaging guidance by clinicians trained in embolization techniques.
- The device should not be used when the target vessel cannot be safely accessed or when vessel anatomy prevents stable deployment; contraindications and warnings in the current labeling must be reviewed.
- MRI safety depends on the current device labeling and any implanted configuration. Confirm MR conditions with the manufacturer or official instructions for use before scanning.
- Potential procedural concerns include malposition, migration, incomplete occlusion, vessel injury, non-target embolization and access-site complications.
Procedures that use this device
Frequently Asked Questions
What is the Medusa Vascular Plug used for?
The Medusa Vascular Plug is used to occlude or block blood vessels, often in the treatment of vascular abnormalities or to control bleeding.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use the Medusa Vascular Plug.
What are the FDA-cleared indications?
The device is indicated for the occlusion of peripheral blood vessels, useful in managing vascular malformations and controlling hemorrhage.
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.