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navien intracranial support catheter
Micro Therapeutics Inc., D/B/A Ev3 Neurovascular
Summary: The Navien Intracranial Support Catheter is designed for endovascular treatment, providing stable access for neurovascular interventions. Key evidence highlights its flexibility and effectiveness in complex cerebrovascular procedures.
FDA Clearance Information
Pathway
510K
Number
K161152 ↗
Decision Date
October 12, 2016
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Navien Intracranial Support Catheter was cleared through the FDA 510(k) pathway on October 12, 2016. Manufactured by Micro Therapeutics Inc., it is classified as a Class 2 device under product code DQY.
What It Is
The Navien Intracranial Support Catheter is a flexible catheter used in neuroendovascular procedures to provide stable and safe access to the intracranial vasculature. It is intended for use in the treatment of cerebrovascular conditions requiring endovascular intervention.
Clinical Applications
Commonly used in procedures involving intracranial atherosclerotic stenosis and aneurysm treatment, the Navien catheter facilitates access in complex vascular anatomies, including tortuous vessels and hypoplastic vertebral arteries.
Evidence Summary
The literature includes six studies, comprising RCTs, case reports, and retrospective analyses, conducted between 2014 and 2020. These studies explore the catheter's application in various neuroendovascular interventions.
Reported Outcomes
Published studies report that the Navien catheter provides effective support in neuroendovascular procedures, enhancing access and stability. Its use in conjunction with other devices has shown technical success in treating complex vascular conditions.
Safety Profile
Reported complications include issues related to catheter navigation in tortuous vessels, although these are infrequent. Overall, the device is considered safe when used by experienced clinicians in appropriate settings.
Evidence Limitations
Current evidence is limited by the small sample sizes and the retrospective nature of some studies. Further research is needed to establish long-term outcomes and to evaluate its efficacy across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Navien Intracranial Support Catheter?
The catheter is indicated for use in neuroendovascular procedures requiring stable intracranial access, such as the treatment of atherosclerotic stenosis and aneurysms.
What outcomes have been reported in clinical studies?
Studies have reported successful access and stability in complex neurovascular procedures, with effective outcomes in treating intracranial conditions.
What complications have been reported?
Safety data indicate rare complications related to navigation in tortuous vessels, but overall, the device is considered safe in experienced hands.
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.