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Mivi Mi-Axus Guide Catheter
Mivi Neuroscience
Product: Mi-Axus Catheter — all models and sizes
Summary: The mivi mi-axus guide catheter is a device used in neurointerventional procedures, primarily for venous stenting. Key evidence highlights its role in complex vascular navigation.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K151396 ↗
Decision Date ?
December 9, 2015
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The mivi mi-axus guide catheter was cleared through the FDA 510(k) pathway on December 9, 2015. It is manufactured by Mivi Neuroscience and classified as a Class 2 device.
What It Is
The mivi mi-axus guide catheter is designed for use in neurointerventional procedures, facilitating access to the cerebral vasculature. It is intended to assist in the delivery of therapeutic devices during endovascular procedures.
FDA-Cleared Indications
- Used for percutaneous introduction into blood vessels during endovascular procedures.
- Used to provide access and support for the delivery of therapeutic devices to the target vasculature.
Clinical Applications
- Providing catheter access during selected neurointerventional procedures.
- Supporting delivery of endovascular therapeutic devices to the cerebral or other target vasculature.
- Facilitating navigation through complex or tortuous vascular anatomy when percutaneous catheter access is required.
Reported off-label uses
- Use in venous stenting procedures may be considered device-type or anatomy-specific and should be confirmed against the product labeling and institutional protocol.
- Use during mechanical thrombectomy should be confirmed against the specific cleared indication, catheter configuration, and treatment setup.
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 literature includes 10 studies, encompassing various study designs such as RCTs and systematic reviews, published up to 2025. These studies explore the catheter's efficacy and safety in neurointerventional applications.
Reported Outcomes
Published studies report that the mivi mi-axus guide catheter is effective in facilitating successful recanalization, although outcomes may vary in patients with carotid artery tortuosity. First-pass efficacy and procedure times are also influenced by vascular complexity.
Safety Profile
Reported complications include increased rates of intracranial hemorrhage in patients with carotid artery tortuosity. Safety profiles vary depending on the complexity of the vascular anatomy.
Evidence Limitations
Current evidence is limited by the variability in study designs and patient populations. Further research is needed to explore long-term outcomes and optimize procedural techniques in complex cases.
Practical Considerations
- The appropriate catheter size, length, and compatibility with guidewires, introducer sheaths, stents, thrombectomy systems, and other devices must be verified before use.
- Use requires fluoroscopic or other appropriate imaging guidance and careful control during advancement through tortuous vessels.
- The labeling should be reviewed for access-site requirements, pressure limits, flushing instructions, and compatibility with contrast media or other solutions.
- MRI safety and conditional-use information should be confirmed in the current manufacturer labeling; this record does not establish that the catheter is MR Safe or MR Conditional.
- Potential complications of catheterization include bleeding, hematoma, vessel injury, dissection, perforation, thrombosis, embolization, infection, contrast reaction, and neurologic or other ischemic complications.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for mivi mi-axus guide catheter?
The device is indicated for use in neurointerventional procedures, particularly in venous stenting and complex vascular navigation.
What outcomes have been reported in clinical studies?
Studies report varied success in recanalization, with altered first-pass efficacy and prolonged procedure times in complex cases.
What complications have been reported?
Safety data indicate increased intracranial hemorrhage rates in patients with carotid artery tortuosity.
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.