📊 Evidence-Based Reference
Sofia 6f Catheter
Summary: The Sofia 6F catheter by Microvention is used primarily for aspiration thrombectomy in acute ischemic stroke. Key evidence suggests its efficacy as both an aspiration and intermediate catheter.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K150366 ↗
Decision Date ?
March 27, 2015
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Sofia 6F catheter was cleared via the FDA 510(k) pathway on March 27, 2015. It is manufactured by Microvention and classified as a Class 2 device.
What It Is
The Sofia 6F catheter is a soft torqueable catheter optimized for intracranial access. It is designed for use in aspiration thrombectomy procedures, particularly in cases of acute ischemic stroke.
FDA-Cleared Indications
- Percutaneous introduction into blood vessels for the delivery or removal of fluids, materials, or other devices during diagnostic or therapeutic procedures.
- Use as a catheter component in endovascular procedures when access to the target vessel is required.
Clinical Applications
- Percutaneous catheter access to blood vessels during endovascular procedures.
- Delivery or removal of fluids, materials, or other devices through the vascular system.
- Use as an access or intermediate catheter during catheter-based vascular interventions.
Reported off-label uses
- Aspiration thrombectomy for acute ischemic stroke, when used for clot aspiration in cerebral arteries.
- Use as an intermediate catheter to support delivery of a stent retriever during neurointerventional thrombectomy.
- Aspiration or clot-removal procedures in selected peripheral or venous vessels, when appropriate for the catheter size and anatomy.
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 two studies: one published in 2021 and another with an unknown date. These studies encompass various methodologies, including RCTs and prospective analyses.
Reported Outcomes
Published studies report that the Sofia 6F catheter is effective in aspiration thrombectomy for acute ischemic stroke. It is noted for its large luminal diameter, which enhances its functionality as both an aspiration and intermediate catheter.
Safety Profile
Reported complications include those typical of endovascular procedures, though specific adverse events were not detailed in the provided studies. Further safety data is needed for comprehensive assessment.
Evidence Limitations
The evidence is limited by the small number of studies and lack of detailed safety outcomes. Further research is needed to establish long-term efficacy and safety profiles.
Practical Considerations
- The catheter is a 6 French device; the inner diameter, distal tip configuration, working length, and other model-specific specifications should be confirmed in the current manufacturer instructions for use.
- Compatibility with guidewires, aspiration tubing, syringes, pumps, and other devices must be checked before use.
- Use fluoroscopic or other appropriate image guidance and follow standard catheter, anticoagulation, and vascular-access protocols.
- MRI safety and conditional-use requirements depend on the specific model and labeling; verify the current manufacturer MRI information before scanning.
- Contraindications and warnings include inability to safely access the target vessel, severe vascular disease or spasm, vessel perforation risk, thrombus-related complications, bleeding, infection, and contrast-related reactions.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for Sofia 6F catheter?
The Sofia 6F catheter is indicated for use in aspiration thrombectomy procedures, particularly in acute ischemic stroke.
What outcomes have been reported in clinical studies?
Studies report the Sofia 6F catheter is effective in aspiration thrombectomy, with its large luminal diameter enhancing its performance.
What complications have been reported?
Reported complications include general risks associated with endovascular procedures, though specific adverse events were not detailed in the studies provided.
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.