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Neuron Max System
Product: Neuron — all models and sizes
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 ?
510(k)
Number ?
K111380 ↗
Decision Date ?
July 19, 2011
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Percutaneous catheter intended for use in endovascular procedures.
- Used to provide access to and support delivery of compatible interventional devices.
- FDA clearance does not, based on the supplied text, establish a specific indication for venous stenting or DVT thrombectomy.
Clinical Applications
- Providing endovascular access during image-guided vascular procedures.
- Supporting the introduction and exchange of compatible catheters or other interventional devices.
- Use in selected peripheral or central vascular procedures when the catheter size and anatomy are compatible.
Reported off-label uses
- Use as a large-bore access or support catheter during venous stenting procedures.
- Use as an access catheter during mechanical thrombectomy for deep vein thrombosis.
- Use in other complex endovascular procedures requiring stable proximal support, when selected by the treating clinician.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
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.
Practical Considerations
- The exact device size, working length, inner diameter, and outer diameter should be confirmed in the current manufacturer instructions for use before use.
- Compatibility depends on the guidewire, introducer sheath, catheter, stent-delivery system, or thrombectomy device being used.
- The catheter is advanced under fluoroscopic or other appropriate image guidance; careful attention is required to vessel size, tortuosity, spasm, dissection, and perforation risk.
- MRI safety should be verified in the current labeling for the specific Neuron MAX configuration. Do not assume the device is safe for MRI without confirming its MR status.
- Potential risks include bleeding, hematoma, infection, thrombosis, embolization, vessel injury, dissection, perforation, and complications related to contrast or radiation.
Procedures that use this device
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.