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Mreye Embolization Coil
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 ?
510(k)
Number ?
K052834 ↗
Decision Date ?
November 23, 2005
Product Code ?
KRD Device, Vascular, For Promoting Embolization
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.
FDA-Cleared Indications
- Intended for vascular occlusion to promote embolization.
- Used to reduce or stop blood flow in selected vessels during endovascular treatment of vascular abnormalities.
- Use is limited by the device labeling, compatible delivery system, vessel anatomy, and physician judgment.
Clinical Applications
- Embolization of selected renal artery pseudoaneurysms or other visceral vascular abnormalities.
- Occlusion of selected iliac or other peripheral vessels when embolization is clinically indicated.
- Treatment of selected aneurysms and pseudoaneurysms by promoting thrombosis and vessel occlusion.
- Endovascular control of bleeding from an appropriate target vessel.
- Selected congenital or acquired vascular abnormalities when the anatomy and device labeling are appropriate.
Reported off-label uses
- Embolization of selected bronchial, gastroduodenal, splenic, or other visceral arteries.
- Embolization of pelvic venous or arterial conditions, including selected varicocele or pelvic congestion procedures.
- Use in selected neurovascular embolization procedures when the device, delivery system, and anatomy are appropriate; neurovascular use should not be assumed to be FDA-labeled.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
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.
Practical Considerations
- The available coil diameters, lengths, and delivery-system compatibility must match the target vessel and treatment plan; the current manufacturer instructions for use should be checked.
- The coil is delivered through a catheter under fluoroscopic or other appropriate imaging guidance. Accurate catheter positioning is required to avoid non-target embolization.
- Potential complications include coil migration, non-target embolization, vessel injury, thrombosis, recanalization, infection, bleeding, and complications related to vascular access.
- MRI conditions should be confirmed from the current Cook labeling and the specific coil configuration. Non-ferromagnetic does not by itself establish that every MRI field strength or scanning condition is safe.
- Contraindications and precautions include unsuitable vessel size or anatomy, inability to safely catheterize the target, active infection at the treatment site, allergy to relevant materials or contrast media, and uncorrected bleeding or clotting disorders.
Procedures that use this device
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.