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mivi mi-axus guide catheter
Mivi Neuroscience
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
510K
Number
K151396 ↗
Decision Date
December 9, 2015
Product Code
DQY
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.
Clinical Applications
This catheter is commonly used in scenarios requiring precise navigation through tortuous vascular pathways, such as during mechanical thrombectomy or venous stenting procedures.
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.
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.