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benchmark intracranial access system
Penumbra
Summary: The Benchmark Intracranial Access System by Penumbra is a device used for intracranial procedures, primarily in venous stenting. Key evidence includes studies on its technical performance and safety profile.
FDA Clearance Information
Pathway
510K
Number
K142321 ↗
Decision Date
January 26, 2015
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Benchmark Intracranial Access System was cleared by the FDA via the 510(k) pathway on January 26, 2015. It is manufactured by Penumbra and classified as a Class 2 device under product code DQY.
What It Is
The Benchmark Intracranial Access System is designed to facilitate access to the intracranial vasculature for diagnostic and interventional procedures. It is intended for use in neurointerventional procedures, particularly those involving venous stenting.
Clinical Applications
Common clinical scenarios for the Benchmark Intracranial Access System include procedures requiring access to the intracranial venous system, such as the treatment of intracranial aneurysms or other neurovascular conditions.
Evidence Summary
The available literature includes 14 studies, encompassing various study types such as RCTs and case series, with publication dates ranging from 2021 to 2024. These studies provide insights into the device's efficacy and safety.
Reported Outcomes
Published studies report that the Benchmark Intracranial Access System demonstrates reliable technical performance in accessing the intracranial vasculature. Outcomes include successful deployment in neurointerventional procedures with a favorable safety profile.
Safety Profile
Reported complications include technical challenges related to vascular access and potential procedural complications. However, the device generally maintains a reliable safety profile in clinical use.
Evidence Limitations
Current evidence is limited by the small sample sizes and the need for more comprehensive studies to evaluate long-term outcomes. Further research is needed to explore broader clinical applications and optimize procedural techniques.
Frequently Asked Questions
What are the clinical indications for Benchmark Intracranial Access System?
The device is indicated for use in neurointerventional procedures requiring access to the intracranial vasculature, such as venous stenting.
What outcomes have been reported in clinical studies?
Studies report successful technical performance and deployment in neurointerventional procedures with a favorable safety profile.
What complications have been reported?
Safety data indicate potential technical challenges and procedural complications, though the device generally maintains a reliable safety profile.
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.