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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 90% achieving RROC I or II.
FDA Clearance Information
Pathway
510K
Number
K143218 ↗
Decision Date
March 18, 2015
Product Code
HCG
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.
Clinical Applications
The device is commonly used in endovascular procedures for patients with intracranial aneurysms and other vascular malformations. It provides a minimally invasive option for embolization, reducing the need for open surgery.
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.
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.