đź“Š Evidence-Based Reference
Penumbra Smart Coil
Product: Smart Coil — all models and sizes
Summary: The Penumbra SMART COIL is an embolic coil system used primarily for treating intracranial aneurysms and vascular malformations. Key evidence shows a 6.8% retreatment rate at 1 year and a 90% occlusion rate for aneurysms.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K151572 ↗
Decision Date ?
July 10, 2015
Product Code ?
HCG Device, Neurovascular Embolization
Device Class ?
Class 2
Evidence ?
0 studies
The Penumbra SMART COIL received FDA clearance through the 510(k) pathway on July 10, 2015. It is manufactured by Penumbra and is classified as a Class II device.
What It Is
The Penumbra SMART COIL is a mechanical thrombectomy device designed for endovascular embolization of neurovascular lesions. It features varying stiffness to accommodate different clinical scenarios, primarily used for intracranial aneurysms.
FDA-Cleared Indications
- Endovascular embolization of intracranial aneurysms
- Endovascular embolization of selected neurovascular vascular malformations or fistulas, as covered by the device labeling
Clinical Applications
- Coil embolization of selected saccular intracranial aneurysms
- Treatment of intracranial aneurysms when the target anatomy is suitable for detachable-coil embolization
- Embolization of selected neurovascular arteriovenous fistulas or vascular malformations when covered by the applicable labeling
- Adjunctive aneurysm treatment with balloon- or stent-assisted coiling when the overall treatment plan and device labeling permit
Reported off-label uses
- Embolization of selected extracranial or peripheral vascular lesions using detachable-coil techniques
- Treatment of selected dural arteriovenous fistulas or other neurovascular shunts outside the specific cleared indication
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 available literature includes 9 studies, comprising prospective registries and subset analyses, conducted between 2022 and 2024. These studies provide insights into the device's efficacy and safety in real-world settings.
Reported Outcomes
Published studies report a 6.8% retreatment rate at 1 year and a 90% occlusion rate for aneurysms using the Raymond Roy Occlusion Classification. Additionally, 83.1% of patients achieved a Modified Rankin Scale score of 0-2, indicating favorable outcomes.
Safety Profile
Reported complications include a 2.6% rate of procedural device-related serious adverse events. These findings highlight the importance of careful procedural planning and execution.
Evidence Limitations
The evidence is primarily derived from registry data, which may not capture all potential complications or long-term outcomes. Further randomized controlled trials are needed to validate these findings and explore additional clinical applications.
Practical Considerations
- The coil is delivered through a compatible microcatheter selected for the coil diameter, length, and delivery-wire system; catheter and coil compatibility must be confirmed before use.
- Multiple coil sizes and varying stiffness are available. Selection depends on the aneurysm or lesion size, shape, neck, packing strategy, and parent-vessel anatomy.
- Placement is performed under fluoroscopic angiographic guidance, usually through femoral or radial arterial access, with local anesthesia and sedation or general anesthesia depending on the case.
- MRI eligibility depends on the specific coil configuration and the manufacturer's current labeling. The exact device and implant conditions should be verified before MRI.
- Important risks include thromboembolism, vessel perforation or dissection, hemorrhage, ischemic stroke, coil migration or compaction, incomplete occlusion, recurrence, and the need for retreatment.
Frequently Asked Questions
What are the clinical indications for Penumbra SMART COIL?
The device is indicated for the treatment of intracranial aneurysms and arteriovenous fistulas, as supported by clinical studies.
What outcomes have been reported in clinical studies?
Studies report a 6.8% retreatment rate at 1 year and a 90% occlusion rate for aneurysms, with 83.1% of patients achieving a favorable Modified Rankin Scale score.
What complications have been reported?
Safety data indicate a 2.6% rate of procedural device-related serious adverse events.
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.