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mreye embolization coil
Cook
Summary: The MReye embolization coil is a device used for vascular occlusion in embolization procedures. It is primarily used to treat aneurysms and other vascular abnormalities. Key evidence suggests its efficacy in managing pseudoaneurysms post-surgical interventions.
FDA Clearance Information
Pathway
510K
Number
K052834 ↗
Decision Date
November 23, 2005
Product Code
KRD
Device Class
Class 2
Evidence
0 studies
The MReye embolization coil was cleared by the FDA through the 510(k) pathway on November 23, 2005. It is manufactured by Cook and classified as a Class 2 medical device.
What It Is
The MReye embolization coil is a non-ferromagnetic device designed for endovascular embolization. It is used to occlude blood vessels, thereby preventing blood flow to specific areas, which is beneficial in treating aneurysms and other vascular conditions.
Clinical Applications
Common clinical scenarios for the MReye embolization coil include the treatment of renal artery pseudoaneurysms, iliac artery ruptures, and patent ductus arteriosus. It is often used in endovascular procedures to prevent hemorrhage and manage vascular abnormalities.
Evidence Summary
The available literature includes a mix of case series and other study types, with a total of 7 studies ranging from 2002 to 2024. These studies explore the device's use in various vascular conditions and its effectiveness in embolization procedures.
Reported Outcomes
Published studies report successful occlusion of pseudoaneurysms and other vascular abnormalities using the MReye embolization coil. In cases of renal artery pseudoaneurysm post-PCNL, the coil effectively managed gross hematuria. The device has also been used in transcatheter closure of patent ductus arteriosus.
Safety Profile
Reported complications include potential access site issues, such as those from femoral or brachial artery access. However, specific adverse events related to the coil itself are not extensively detailed in the available studies.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of large-scale randomized controlled trials. Further research is needed to establish long-term safety and efficacy, as well as to explore outcomes in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for MReye embolization coil?
The MReye embolization coil is indicated for vascular occlusion in embolization procedures, particularly in treating aneurysms and vascular abnormalities.
What outcomes have been reported in clinical studies?
Clinical studies have reported successful occlusion of pseudoaneurysms and effective management of vascular conditions such as patent ductus arteriosus.
What complications have been reported?
Reported complications include access site issues, but specific adverse events related to the coil itself are not extensively detailed.
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.