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penumbra smart coil
Penumbra
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
510K
Number
K151572 ↗
Decision Date
July 10, 2015
Product Code
HCG
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.
Clinical Applications
The device is commonly used in the treatment of saccular intracranial aneurysms and arteriovenous fistulas. It is employed in endovascular procedures to achieve occlusion of the target lesion.
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.
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.