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sofia distal access catheter
Microvention
Summary: The Sofia Distal Access Catheter by Microvention is primarily used for endovascular treatment of acute ischemic stroke. Key evidence highlights its effectiveness in direct aspiration techniques.
FDA Clearance Information
Pathway
510K
Number
K131482 ↗
Decision Date
November 22, 2013
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Sofia Distal Access Catheter was cleared by the FDA through the 510(k) pathway on November 22, 2013. It is manufactured by Microvention and is classified as a Class 2 device.
What It Is
The Sofia Distal Access Catheter is a soft, torqueable catheter optimized for intracranial access. It is intended for use in neurovascular procedures, particularly for aspiration thrombectomy in acute ischemic stroke.
Clinical Applications
Commonly used in the treatment of acute ischemic stroke, the Sofia catheter is employed in direct aspiration techniques to remove thrombi from cerebral arteries. It is also used in cases of middle cerebral artery occlusion.
Evidence Summary
The available literature includes 13 studies, comprising retrospective and observational studies, with publication dates ranging from 2021 to 2025. These studies explore clinical, technical, and safety outcomes of the Sofia catheter.
Reported Outcomes
Published studies report that the Sofia catheter is effective in direct aspiration during endovascular treatment of acute ischemic stroke. Comparisons between different sizes of the catheter (5Fr vs. 6Fr) indicate varying clinical and technical outcomes. The catheter has been shown to be effective in both distal middle vessel occlusions and large vessel occlusions.
Safety Profile
Reported complications include procedural challenges related to catheter navigation and potential vessel injury. However, studies generally indicate that the device is safe when used appropriately in clinical settings.
Evidence Limitations
Current evidence is limited by the retrospective nature of many studies and the need for larger, randomized controlled trials to better establish efficacy and safety profiles. Further research is needed to compare the Sofia catheter with other thrombectomy devices.
Frequently Asked Questions
What are the clinical indications for the Sofia Distal Access Catheter?
The Sofia Distal Access Catheter is indicated for use in neurovascular procedures, particularly for aspiration thrombectomy in acute ischemic stroke.
What outcomes have been reported in clinical studies?
Clinical studies report effective outcomes in direct aspiration techniques for acute ischemic stroke, with varying results based on catheter size.
What complications have been reported?
Reported complications include procedural challenges and potential vessel injury, though the device is generally considered safe.
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.