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penumbra coil system penumbra coil 400
Penumbra
Summary: The Penumbra Coil System 400 is an embolization coil used for mechanical thrombectomy and embolization procedures. Key evidence highlights its efficacy in treating intracranial aneurysms with a high rate of occlusion and low retreatment rates.
FDA Clearance Information
Pathway 510K
Number K120330 ↗
Decision Date April 2, 2012
Product Code HCG
Device Class Class 2
Evidence 7 studies
The Penumbra Coil System 400 was cleared by the FDA via the 510(k) pathway on April 2, 2012. It is manufactured by Penumbra and classified as a Class 2 device.
What It Is
The Penumbra Coil System 400 is a medical device designed for embolization procedures, particularly in neurovascular applications. It functions by occluding blood vessels to prevent blood flow to specific areas, aiding in the treatment of conditions like aneurysms.
Clinical Applications
This device is commonly used in the treatment of intracranial aneurysms and arteriovenous fistulas. It is employed in endovascular procedures to achieve vessel occlusion and prevent hemorrhagic events.
Evidence Summary
The available literature includes 15 studies, comprising prospective registries and case series, conducted from 2022 to 2024. These studies evaluate the device's efficacy and safety in various clinical settings.
Reported Outcomes
Published studies report a 6.8% retreatment rate at 1 year and a 90.0% rate of achieving 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 suggest a relatively low incidence of adverse events associated with the device.
Evidence Limitations
The evidence is primarily derived from registry data and case series, which may limit the generalizability of findings. Further randomized controlled trials are needed to strengthen the evidence base and explore long-term outcomes.
Linked Studies (7)
PubMed • 2024
OnyxTMGel or Coil versus Hydrogel as Embolic Agents in Endovascular Applications: Review of the Literature and Case Series.
Gels (Basel, Switzerland)
View Source → PubMed • 2024
The SMART Registry: Long-Term Results on the Utility of the Penumbra SMART COIL System for Treatment of Intracranial Aneurysms and Other Malformations.
Frontiers in neurology
Prospective View Source → PubMed • 2015
The penumbra coil 400 system for treatment of wide-necked intracranial aneurysms: initial single-center experience.
Acta neurochirurgica. Supplement
Other View Source → PubMed • 2014
Initial experience using the Penumbra coil 400: comparison of aneurysm packing, cost effectiveness, and coil efficiency.
Journal of neurointerventional surgery
Retrospective View Source → PubMed • 2014
Initial experience with Penumbra Coil 400 versus standard coils in embolization of cerebral aneurysms: a retrospective review.
Journal of neurointerventional surgery
Retrospective View Source → ClinicalTrials.gov
CARE: A Prospective Multicenter Case Study to Assess Radiation Exposure in Patients Treated With the Penumbra Coil 400
View Source →Frequently Asked Questions
What are the clinical indications for Penumbra Coil System Penumbra Coil 400?
The device is indicated for use in mechanical thrombectomy and embolization procedures, particularly for treating intracranial aneurysms and arteriovenous fistulas.
What outcomes have been reported in clinical studies?
Clinical studies have reported a 6.8% retreatment rate at 1 year and a 90.0% rate of achieving Raymond Roy Occlusion Classification I or II for aneurysms.
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.