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penumbra smart coil
Penumbra
Summary: The Penumbra SMART COIL is an embolic coil system used primarily for treating intracranial aneurysms. Key evidence shows a 6.8% retreatment rate at 1 year and a 90% occlusion rate.
FDA Clearance Information
Pathway
510K
Number
K160832 ↗
Decision Date
April 20, 2016
Product Code
HCG
Device Class
Class 2
Evidence
0 studies
The Penumbra SMART COIL received FDA clearance via the 510(k) pathway on April 20, 2016. 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. It is used to treat intracranial aneurysms and other vascular malformations by occluding blood flow to the targeted area.
Clinical Applications
Commonly used in the treatment of intracranial aneurysms, the Penumbra SMART COIL is also applicable in managing arteriovenous fistulas. It is utilized in endovascular procedures to achieve vessel occlusion.
Evidence Summary
The literature includes 9 studies, comprising prospective registries and subset analyses, with data collected from 2022 to 2024. These studies evaluate the efficacy and safety of the SMART COIL in various neurovascular conditions.
Reported Outcomes
Published studies report a 6.8% retreatment rate at 1 year and a 90% occlusion rate (Raymond Roy Occlusion Classification I or II) for aneurysms. 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
Current evidence is limited by the lack of randomized controlled trials and the reliance on registry data. Further research is needed to establish long-term outcomes and compare efficacy with alternative treatments.
Frequently Asked Questions
What are the clinical indications for Penumbra SMART COIL?
The Penumbra SMART COIL is indicated for the treatment of intracranial aneurysms and other vascular malformations requiring endovascular embolization.
What outcomes have been reported in clinical studies?
Clinical studies report a 6.8% retreatment rate at 1 year and a 90% occlusion rate for aneurysms, with 83.1% of patients achieving a Modified Rankin Scale 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.