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sofia ex intracranial support catheter
Microvention
Summary: The Sofia EX Intracranial Support Catheter is a medical device used in neurovascular procedures to provide support during interventions. It is primarily used by interventional neuroradiologists and neurosurgeons.
FDA Clearance Information
Pathway
510K
Number
K182602 ↗
Decision Date
May 15, 2019
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Sofia EX Intracranial Support Catheter was cleared through the FDA 510k pathway on May 15, 2019, by Microvention. It is classified as a Class 2 device under product code DQY.
What It Is
The Sofia EX Intracranial Support Catheter is designed to facilitate access to the neurovasculature and provide support during endovascular procedures. It is a flexible, small-diameter catheter that can navigate the intricate pathways of the brain's blood vessels. Its design allows for the delivery of therapeutic agents or devices, such as stents, to treat conditions like aneurysms or stenosis.
Clinical Applications
This catheter is commonly used in neurointerventional procedures, such as mechanical thrombectomy for acute ischemic stroke or the deployment of intracranial stents. It is utilized in hospital settings, particularly in specialized centers with capabilities for advanced neurovascular interventions. The device is suitable for adult patients requiring endovascular treatment of cerebrovascular conditions.
Indications for Use
The FDA indications for the Sofia EX Intracranial Support Catheter include its use in procedures requiring access to the brain's blood vessels. It is intended for patients needing neurovascular interventions, such as those with blocked or narrowed arteries in the brain.
Practical Considerations
The Sofia EX catheter comes in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with standard neurointerventional equipment and requires careful handling to navigate the delicate cerebral vasculature effectively.
Frequently Asked Questions
What is the Sofia EX Intracranial Support Catheter used for?
It is used to provide support and access during neurovascular procedures, such as treating aneurysms or performing thrombectomy.
What specialties typically use this device?
Interventional neuroradiologists and neurosurgeons typically use this device in neurovascular procedures.
What are the FDA-cleared indications?
The device is indicated for use in accessing and supporting the neurovasculature during endovascular procedures for conditions like aneurysms or stenosis.
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.