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Benchmark Intracranial Access System
Product: Benchmark — all models and sizes
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 ?
510(k)
Number ?
K142321 ↗
Decision Date ?
January 26, 2015
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Provides percutaneous access to the intracranial vasculature for diagnostic and interventional procedures.
- Is intended for use with compatible endovascular devices during neurovascular procedures.
- Use must follow the specific indications, anatomy, compatibility requirements, and instructions for use cleared by the FDA.
Clinical Applications
- Endovascular diagnostic procedures requiring access to intracranial blood vessels.
- Neurovascular interventions in which a guide or access catheter is needed to deliver compatible devices.
- Selected intracranial procedures performed through a percutaneous vascular access route.
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.
Practical Considerations
- The catheter must be used with compatible guidewires, devices, and access equipment specified in the manufacturer’s instructions for use.
- Device selection depends on the required inner diameter, outer diameter, working length, vessel anatomy, and target location.
- Insertion and navigation require fluoroscopic or other appropriate imaging guidance by trained endovascular clinicians.
- Potential complications include vascular injury, dissection, perforation, thromboembolism, infection, bleeding, and neurologic injury.
- MRI safety and conditional-use requirements should be confirmed in the current product labeling; do not assume the device is safe for MRI without verification.
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.