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cook mreye embolization coils
Cook
Summary: Cook MReye Embolization Coils are used for vascular embolization procedures. They are primarily used to occlude blood vessels to prevent or stop bleeding. Key evidence highlights their use in preventing type II endoleaks during endovascular aneurysm repair.
FDA Clearance Information
Pathway
510K
Number
K090624 ↗
Decision Date
April 2, 2009
Product Code
KRD
Device Class
Class 2
Evidence
0 studies
The Cook MReye Embolization Coils were cleared by the FDA through the 510(k) pathway on April 2, 2009. They are manufactured by Cook and classified as Class 2 under product code KRD.
What It Is
Cook MReye Embolization Coils are medical devices used in endovascular procedures to occlude blood vessels. They are designed to induce thrombosis within the vessel, effectively stopping blood flow and preventing hemorrhage.
Clinical Applications
These coils are commonly used in procedures such as endovascular aneurysm repair (EVAR) to prevent endoleaks, and in treating pseudoaneurysms following surgical procedures like percutaneous nephrolithotomy.
Evidence Summary
The literature includes a variety of study types such as case series and real-world data analyses, spanning from 2024 to 2026. Approximately 8 studies have been reviewed, providing insights into the device's efficacy and safety.
Reported Outcomes
Published studies report a high technical success rate of 100% in preventing type II endoleaks during EVAR procedures. In one case series, no reinterventions were required, and only one case of endoleak was detected among five patients.
Safety Profile
Reported complications include no perioperative or postoperative complications in the reviewed studies. The safety profile appears favorable, with no significant adverse events reported in the available literature.
Evidence Limitations
The evidence is limited by small sample sizes and a lack of randomized controlled trials. Further research is needed to confirm long-term outcomes and safety in larger, more diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Cook MReye Embolization Coils?
The coils are indicated for use in vascular embolization procedures, such as preventing type II endoleaks during endovascular aneurysm repair and treating pseudoaneurysms.
What outcomes have been reported in clinical studies?
Studies report a 100% technical success rate in preventing type II endoleaks, with no reinterventions required and minimal complications.
What complications have been reported?
Safety data indicate no perioperative or postoperative complications in the reviewed studies, suggesting a favorable safety profile.
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.