📊 Evidence-Based Reference
Sofia Distal Access Catheter
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 ?
510(k)
Number ?
K131482 ↗
Decision Date ?
November 22, 2013
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- For percutaneous introduction into the peripheral and neurovascular anatomy.
- Used to facilitate the introduction of interventional devices and materials during diagnostic or therapeutic procedures.
- The device is intended for use by physicians trained in endovascular procedures.
Clinical Applications
- Distal catheter access during endovascular neurovascular procedures.
- Support for delivery of compatible catheters, guidewires, embolic materials, or other interventional devices.
- Percutaneous access to selected cerebral and peripheral vessels when appropriate for the catheter size and anatomy.
Reported off-label uses
- Aspiration thrombectomy for acute ischemic stroke, including large-vessel occlusion, when used outside the specific cleared labeling or device configuration.
- Distal access and aspiration support in other neurovascular thrombectomy procedures described in clinical practice.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
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.
Practical Considerations
- Available sizes, inner diameter, outer diameter, length, and distal-tip configuration vary by Sofia catheter model; users should confirm the current product instructions for use.
- The catheter is advanced over a compatible guidewire or through a compatible guide catheter under fluoroscopic imaging. Excessive force, sharp bends, or resistance can damage the catheter or vessel.
- Compatibility with aspiration pumps, guide catheters, microcatheters, guidewires, and other devices must be verified before use.
- MRI safety depends on the exact model and conditions specified in the current labeling. Do not assume MRI compatibility without checking the device's MRI labeling.
- Contraindications and warnings include infection, vessel injury or perforation, thromboembolism, bleeding, vasospasm, and complications related to contrast, anticoagulation, or vascular access.
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.