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Penumbra Embolization Coil System
Product: Penumbra Coil 400 — all models and sizes
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 ?
510(k)
Number ?
K103305 ↗
Decision Date ?
January 26, 2011
Product Code ?
HCG Device, Neurovascular Embolization
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.
FDA-Cleared Indications
- Endovascular embolization of neurovascular abnormalities using detachable embolization coils.
- Treatment of saccular intracranial aneurysms.
- Treatment of cerebral arteriovenous fistulas and other selected neurovascular lesions when embolization is appropriate.
Clinical Applications
- Endovascular coiling of selected saccular brain aneurysms to reduce the risk of rupture or rebleeding.
- Embolization of selected cerebral arteriovenous fistulas.
- Occlusion of abnormal neurovascular channels when a catheter-based coil embolization strategy is selected.
Reported off-label uses
- Embolization of selected peripheral visceral, pelvic, or bronchial arteries.
- Treatment of selected peripheral aneurysms, pseudoaneurysms, or arteriovenous malformations.
- Embolization of selected dialysis-access or venous abnormalities.
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 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.
Practical Considerations
- Coil sizes and configurations must match the target vessel or aneurysm, the delivery catheter, and the intended packing density.
- The system is delivered through a compatible microcatheter under fluoroscopic or angiographic guidance; accurate positioning is required before detachment.
- Potential complications include non-target embolization, vessel perforation, thromboembolism, ischemic stroke, hemorrhage, coil migration, infection, and recurrence or recanalization of the treated lesion.
- MRI safety depends on the specific coil model and labeling. Confirm the exact device and its MR-conditional conditions before MRI.
- Contraindications and precautions include inability to safely catheterize the target vessel, unsuitable vascular anatomy, active infection at the treatment site, severe contrast allergy that cannot be managed, and conditions that prevent appropriate anticoagulation or procedural imaging.
Procedures that use this device
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.