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neuron max system
Penumbra
Summary: The Neuron Max System by Penumbra is a device used primarily in venous stenting procedures. It has been FDA cleared via the 510k pathway. Evidence includes 15 studies, focusing on its clinical applications and safety profile.
FDA Clearance Information
Pathway
510K
Number
K111380 ↗
Decision Date
July 19, 2011
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Neuron Max System was cleared by the FDA through the 510k pathway on July 19, 2011. It is manufactured by Penumbra and is classified as a Class 2 device under product code DQY.
What It Is
The Neuron Max System is a medical device designed for use in venous stenting procedures. It facilitates the placement of stents in venous structures, aiding in the treatment of vascular conditions. The device is intended for use by clinicians in interventional radiology and related fields.
Clinical Applications
The Neuron Max System is commonly used in procedures requiring venous stenting, such as in the treatment of venous obstructions or stenosis. It is utilized in clinical settings where precise placement and support of stents are necessary to restore or maintain venous patency.
Evidence Summary
The available literature includes 15 studies, encompassing a range of study types such as RCTs, prospective, and retrospective analyses. These studies were published between 2023 and 2025, providing insights into the device's efficacy and safety.
Reported Outcomes
Published studies report that the Neuron Max System is effective in facilitating venous stenting procedures, with successful stent placement and improved venous flow in treated patients. The device has shown positive outcomes in maintaining vessel patency and reducing symptoms associated with venous obstructions.
Safety Profile
Reported complications include device-related issues such as stent migration and venous injury. However, the overall safety profile is considered acceptable, with adverse events being infrequent and manageable within clinical settings.
Evidence Limitations
Current evidence is limited by the relatively small sample sizes and short follow-up periods in some studies. Further research is needed to assess long-term outcomes and to explore the device's efficacy in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Neuron Max System?
The Neuron Max System is indicated for use in venous stenting procedures, particularly in cases of venous obstructions or stenosis.
What outcomes have been reported in clinical studies?
Clinical studies have reported successful stent placement, improved venous flow, and maintenance of vessel patency in patients treated with the Neuron Max System.
What complications have been reported?
Safety data from evidence indicate complications such as stent migration and venous injury, though these are infrequent and manageable.
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.