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mreye flipper detachable embolization coil and delivery system
Cook
Summary: The mreye flipper detachable embolization coil is a medical device used to occlude blood vessels. It is primarily used by interventional radiologists and vascular surgeons to treat various vascular conditions.
FDA Clearance Information
Pathway
510K
Number
K150964 ↗
Decision Date
December 18, 2015
Product Code
KRD
Device Class
Class 2
Evidence
0 studies
The mreye flipper detachable embolization coil and delivery system was cleared by the FDA via the 510k pathway on December 18, 2015. Manufactured by Cook, it is classified as a Class 2 medical device.
What It Is
The mreye flipper is a detachable embolization coil designed to occlude blood vessels. It works by being delivered through a catheter to the target site, where it is detached and expands to block blood flow. This device is particularly useful in controlling bleeding or reducing blood flow to specific areas, such as in the treatment of aneurysms or arteriovenous malformations.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings. It is employed in procedures requiring the occlusion of blood vessels, such as treating aneurysms, arteriovenous malformations, or controlling hemorrhage. The typical patient population includes those with vascular abnormalities or trauma requiring minimally invasive intervention.
Indications for Use
The mreye flipper is indicated for use in patients who require embolization to occlude blood vessels. This includes conditions like aneurysms or arteriovenous malformations, where reducing or stopping blood flow is necessary for treatment.
Practical Considerations
The mreye flipper coil comes in various sizes to accommodate different vessel diameters. It is compatible with standard catheter delivery systems used in interventional procedures. Clinicians should be familiar with the detachment mechanism and ensure proper positioning before release.
Related Literature
The linked study compared different transvascular occlusion methods for closing patent ductus arteriosus (PDA) in dogs. It highlighted the effectiveness of various devices, including embolization coils, in achieving successful occlusion. However, the study's limitations include its focus on a canine model, which may not fully translate to human applications.
Frequently Asked Questions
What is the mreye flipper detachable embolization coil used for?
It is used to occlude blood vessels in procedures like treating aneurysms or arteriovenous malformations.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for embolization to occlude blood vessels in conditions like aneurysms or arteriovenous malformations.
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.