📊 Evidence-Based Reference
Embolization Coil System
Summary: The embolization coil system by Cook is used for occluding blood vessels in various clinical scenarios, such as treating aneurysms. Key evidence highlights its efficacy in improving patient outcomes in intracranial aneurysms.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K992121 ↗
Decision Date ?
December 20, 1999
Product Code ?
KRD Device, Vascular, For Promoting Embolization
Device Class ?
Class 2
Evidence ?
0 studies
The embolization coil system by Cook was cleared via the FDA 510(k) pathway on December 20, 1999. It is classified as a Class 2 medical device under product code KRD.
What It Is
The embolization coil system is a medical device designed to occlude blood vessels by deploying coils into the vascular structure. It is primarily used in the treatment of aneurysms and other vascular abnormalities, providing a minimally invasive option for clinicians.
FDA-Cleared Indications
- Promoting embolization or occlusion of blood vessels.
- Use in selected vascular conditions, including aneurysms and other vascular abnormalities, when vessel occlusion is clinically indicated.
Clinical Applications
- Endovascular occlusion of selected arteries or veins.
- Embolization of intracranial aneurysms as part of an endovascular coiling procedure.
- Embolization of congenital portosystemic shunts.
- Treatment of selected aneurysms, pseudoaneurysms, or abnormal vascular connections requiring intentional vessel blockage.
Reported off-label uses
- Embolization of uterine arteries for symptomatic fibroids or postpartum hemorrhage.
- Embolization of prostatic arteries for benign prostatic hyperplasia.
- Embolization of varicoceles, ovarian veins, or other venous insufficiency conditions.
- Embolization for selected gastrointestinal, bronchial, visceral, or pelvic bleeding when clinically appropriate.
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 literature includes 15 studies, comprising randomized controlled trials, prospective and retrospective studies, and case series. The studies span from 2022 to 2025, providing a comprehensive overview of the device's clinical performance.
Reported Outcomes
Published studies report that the embolization coil system is effective in treating small intracranial aneurysms, with favorable long-term clinical and angiographic outcomes. The CATCH trial demonstrated its efficacy compared to other coil systems, highlighting its role in improving patient prognosis.
Safety Profile
Reported complications include device migration and incomplete occlusion, which are common concerns in coil embolization procedures. However, the studies emphasize the importance of proper technique and device selection to minimize these risks.
Evidence Limitations
The evidence is limited by the lack of large-scale randomized trials specifically focusing on the embolization coil system. Further research is needed to explore long-term outcomes and compare its efficacy with newer embolization technologies.
Practical Considerations
- Coils are available in different diameters, lengths, shapes, and thrombogenic designs; the operator selects a size based on the target vessel and intended level of occlusion.
- The coil must be compatible with the delivery catheter and deployed under fluoroscopic or other appropriate imaging guidance.
- Deployment requires accurate catheter positioning because an incorrectly placed coil can obstruct an unintended vessel or migrate.
- MRI conditions depend on the specific Cook coil model, materials, and labeling. The exact device identification should be confirmed before MRI.
- Potential complications include non-target embolization, vessel injury, bleeding, infection, coil migration, recanalization, and ischemia of tissue supplied by the treated vessel.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for the embolization coil system?
The embolization coil system is indicated for the occlusion of blood vessels, commonly used in the treatment of intracranial aneurysms and congenital portosystemic shunts.
What outcomes have been reported in clinical studies?
Clinical studies have reported favorable outcomes in the treatment of small intracranial aneurysms, with improved long-term clinical and angiographic results.
What complications have been reported?
Safety data from studies indicate complications such as device migration and incomplete occlusion, which can be mitigated with proper technique and device selection.
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.