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medusa vascular plug
Endoshape
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
510K
Number
K140796 ↗
Decision Date
December 2, 2014
Product Code
KRD
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.
Clinical Applications
The Medusa Vascular Plug is commonly used in procedures requiring the occlusion of peripheral vessels, such as in the treatment of arteriovenous malformations or to control bleeding in trauma cases. It is particularly useful in interventional radiology and vascular surgery settings, where precise control over blood flow is necessary. The device is suitable for a wide range of patient populations, including those with vascular anomalies or those undergoing embolization procedures.
Indications for Use
The FDA-cleared indications for the Medusa Vascular Plug include the occlusion of peripheral blood vessels. This means it is used in patients who require blockage of specific vessels, such as those with vascular malformations or in cases of hemorrhage.
Practical Considerations
The Medusa Vascular Plug comes in various sizes to accommodate different vessel diameters. It is compatible with standard catheter systems, making it easy to integrate into existing procedural setups. Clinicians should be familiar with catheter-based deployment techniques to ensure proper placement and efficacy.
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.