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sofia distal access catheter
Microvention
Summary: The Sofia Distal Access Catheter by Microvention is a device used for intracranial access in endovascular procedures. It is primarily used in the treatment of acute ischemic stroke. Key evidence highlights its efficacy in direct aspiration techniques.
FDA Clearance Information
Pathway
510K
Number
K142014 ↗
Decision Date
October 10, 2014
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 October 10, 2014. It is manufactured by Microvention and is classified as a Class 2 device.
What It Is
The Sofia Distal Access Catheter is designed for intracranial access during endovascular procedures. It features a soft, torqueable design optimized for navigating cerebral vasculature. It is intended for use in neurointerventional procedures, particularly in the treatment of acute ischemic stroke.
Clinical Applications
Commonly used in the management of acute ischemic stroke, the Sofia Distal Access Catheter facilitates direct aspiration thrombectomy. It is also employed in procedures involving distal middle vessel occlusions and large vessel occlusions with challenging anatomy.
Evidence Summary
The literature includes 13 studies, comprising retrospective and prospective analyses, case-control studies, and registry data. These studies span from 2021 to 2025, providing insights into the clinical, technical, and safety outcomes of the device.
Reported Outcomes
Published studies report that the Sofia Distal Access Catheter is effective in direct aspiration during endovascular treatment of acute ischemic stroke. Comparisons between different catheter sizes (5Fr vs. 6Fr) indicate similar efficacy and safety profiles. The device has shown promise in treating both distal and large vessel occlusions.
Safety Profile
Reported complications include device-related technical issues and procedural complications typical of endovascular interventions. However, the overall safety profile is consistent with other devices used in similar clinical scenarios.
Evidence Limitations
Current evidence is limited by the retrospective nature of many studies and the lack of large-scale randomized controlled trials. Further research is needed to establish long-term outcomes and to compare the device directly with alternative treatment methods.
Frequently Asked Questions
What are the clinical indications for Sofia Distal Access Catheter?
The Sofia Distal Access Catheter is indicated for use in neurointerventional procedures, particularly for direct aspiration thrombectomy in acute ischemic stroke.
What outcomes have been reported in clinical studies?
Clinical studies have reported effective outcomes in direct aspiration techniques for acute ischemic stroke, with similar efficacy between different catheter sizes.
What complications have been reported?
Reported complications include device-related technical issues and procedural complications, though the safety profile is generally favorable.
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.