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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 90% achieving RROC I or II.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K143218 ↗
Decision Date ?
March 18, 2015
Product Code ?
HCG Device, Neurovascular Embolization
Device Class ?
Class 2
Evidence ?
0 studies
The Penumbra SMART COIL received FDA clearance via the 510(k) pathway on March 18, 2015. It is manufactured by Penumbra and classified as a Class 2 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 anatomical needs, primarily used in treating intracranial aneurysms.
FDA-Cleared Indications
- Embolization of intracranial aneurysms and other neurovascular lesions when treatment with detachable coils is appropriate.
- Use through a compatible catheter to promote occlusion of a targeted blood vessel or vascular lesion.
Clinical Applications
- Endovascular coil embolization of selected intracranial aneurysms.
- Embolization of selected intracranial vascular malformations or other neurovascular lesions.
- Placement of detachable coils through a microcatheter to reduce or stop blood flow in a targeted lesion.
Reported off-label uses
- Embolization of selected extracranial or peripheral vascular lesions when a clinician determines that the coil is appropriate, although these applications may not be included in the device labeling.
- Adjunctive vessel occlusion in selected hemorrhage or fistula procedures, depending on the specific coil size, anatomy, and regulatory labeling.
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, primarily prospective registries and subset analyses, conducted between 2022 and 2024. These studies evaluate the efficacy and safety of the SMART COIL in various neurovascular applications.
Reported Outcomes
Published studies report a 6.8% retreatment rate at 1-year and 90% of patients achieving Raymond Roy Occlusion Classification (RROC) I or II for aneurysms. Additionally, 83.1% of patients had a Modified Rankin Scale (mRS) score of 0-2, indicating favorable outcomes.
Safety Profile
Reported complications include a 2.6% rate of procedural device-related serious adverse events. The studies highlight the importance of careful patient selection and procedural expertise to minimize risks.
Evidence Limitations
The evidence is primarily derived from registry data, which may have inherent biases and limitations in generalizability. Further randomized controlled trials are needed to strengthen the evidence base and explore long-term outcomes.
Practical Considerations
- The coil is delivered through a compatible microcatheter; the treating physician selects coil diameter, length, and stiffness based on the lesion and vessel anatomy.
- Device compatibility, delivery-system specifications, and coil-release requirements should be confirmed in the current manufacturer instructions for use.
- MRI safety depends on the exact SMART COIL model and the conditions stated in its labeling. The patient should provide the implant information before an MRI examination.
- Potential complications include thromboembolism, vessel perforation or dissection, hemorrhage, incomplete occlusion, coil migration, and need for retreatment.
- Contraindications and warnings include unsuitable vascular anatomy, inability to safely access the lesion, active infection at the treatment site, or inability to tolerate the required angiographic procedure and antithrombotic management.
Frequently Asked Questions
What are the clinical indications for Penumbra SMART COIL?
The device is indicated for the endovascular treatment of intracranial aneurysms and other vascular malformations.
What outcomes have been reported in clinical studies?
Studies report a 6.8% retreatment rate at 1-year and 90% achieving RROC I or II for aneurysms, with 83.1% having an mRS score of 0-2.
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.