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penumbra embolization coil system
Penumbra
Summary: The Penumbra Embolization Coil System is used for endovascular embolization, primarily in treating aneurysms and arteriovenous malformations. Key evidence highlights its efficacy and safety in various clinical settings.
FDA Clearance Information
Pathway
510K
Number
K103305 ↗
Decision Date
January 26, 2011
Product Code
HCG
Device Class
Class 2
Evidence
0 studies
The Penumbra Embolization Coil System was cleared by the FDA via the 510(k) pathway on January 26, 2011. It is manufactured by Penumbra and classified as a Class 2 device.
What It Is
The Penumbra Embolization Coil System is a medical device used for endovascular embolization. It is designed to occlude blood vessels, primarily for treating aneurysms and arteriovenous malformations, by deploying coils that induce clot formation.
Clinical Applications
This device is commonly used in the treatment of saccular intracranial aneurysms and arteriovenous fistulas. It is applied in scenarios requiring precise embolization to prevent rupture or reduce blood flow to abnormal vascular structures.
Evidence Summary
The literature includes 15 studies, comprising prospective and retrospective analyses, registries, and case series, conducted between 2014 and 2024. These studies evaluate the device's efficacy and safety in various clinical applications.
Reported Outcomes
Published studies report that the Penumbra Embolization Coil System demonstrates high technical success rates in embolizing saccular intracranial aneurysms and arteriovenous fistulas. The SMART Registry highlights its effectiveness in treating lesions 4 mm and smaller, with positive long-term outcomes.
Safety Profile
Reported complications include periprocedural risks such as coil migration and vessel perforation. However, studies from the SMART Registry indicate a favorable safety profile with minimal adverse events in most cases.
Evidence Limitations
Current evidence is limited by the retrospective nature of some studies and the lack of randomized controlled trials. Further research is needed to explore long-term outcomes and compare the device with alternative embolization techniques.
Frequently Asked Questions
What are the clinical indications for the Penumbra Embolization Coil System?
The device is indicated for the embolization of saccular intracranial aneurysms and arteriovenous malformations, as supported by clinical studies.
What outcomes have been reported in clinical studies?
Studies report high technical success and efficacy in treating intracranial aneurysms and arteriovenous fistulas, with positive long-term outcomes.
What complications have been reported?
Safety data indicate potential complications such as coil migration and vessel perforation, though these are relatively infrequent.
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.