đź“‹ FDA Reference
nester embolization coils tornado embolization coils
Cook
Summary: Nester and Tornado embolization coils are used to occlude blood vessels in various interventional radiology procedures. They are primarily used by interventional radiologists to treat conditions like aneurysms and varicoceles.
FDA Clearance Information
Pathway
510K
Number
K153778 ↗
Decision Date
May 19, 2016
Product Code
KRD
Device Class
Class 2
Evidence
0 studies
The Nester and Tornado embolization coils by Cook were cleared via the FDA 510(k) pathway on May 19, 2016. They are classified as Class 2 medical devices.
What It Is
The Nester and Tornado embolization coils are small, flexible coils used to block blood flow in targeted blood vessels. These coils are inserted through a catheter and deployed in the vessel, where they expand and induce clot formation, effectively occluding the vessel. This process is used to treat conditions such as aneurysms, arteriovenous malformations, and other vascular abnormalities.
Clinical Applications
These embolization coils are commonly used in interventional radiology to manage vascular conditions. They are often employed in procedures to treat aneurysms, gastrointestinal bleeding, and varicoceles. The coils are used in both elective and emergency settings, and are suitable for a wide range of patient populations, including those with complex vascular anatomy.
Indications for Use
The FDA-cleared indications for these embolization coils include the occlusion of blood vessels to treat conditions like aneurysms and vascular malformations. They are used when it is necessary to block blood flow to a specific area to prevent bleeding or reduce blood supply to a lesion.
Practical Considerations
The coils come in various sizes to accommodate different vessel diameters and are compatible with standard catheter systems. Proper sizing and placement technique are crucial for effective occlusion and minimizing complications. Clinicians should be familiar with the catheterization techniques required for deploying these coils.
Related Literature
The linked study examined the use of real-world data to assess the safety and performance of embolization coils post-market. It highlighted the challenges of transforming electronic health records into real-world evidence due to the broad clinical use and long-term follow-up required for these devices. The study emphasized the importance of post-market surveillance in understanding device performance beyond pre-market clinical trials.
Frequently Asked Questions
What is Nester & Tornado embolization coils used for?
They are used to occlude blood vessels in procedures treating aneurysms, arteriovenous malformations, and other vascular conditions.
What specialties typically use this device?
Interventional radiologists primarily use these devices in both hospital and outpatient settings.
What are the FDA-cleared indications?
These coils are indicated for the occlusion of blood vessels to prevent bleeding or reduce blood flow to specific areas.
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.