📊 Evidence-Based Reference
Sofia 88 Catheter
Product: Sofia 88 — all models and sizes · Where to buy
Summary: The Sofia 88 Catheter by Microvention is a medical device used primarily in venous stenting procedures. It has been FDA-cleared through the 510k pathway. Key evidence highlights its role in improving procedural success in aspiration thrombectomy.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K214024 ↗
Decision Date ?
September 12, 2022
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Sofia 88 Catheter received FDA clearance via the 510k pathway on September 12, 2022. It is manufactured by Microvention and is classified as a Class 2 medical device.
What It Is
The Sofia 88 Catheter is designed for use in venous stenting procedures. It aids in the delivery of aspiration catheters, particularly in challenging anatomical scenarios, by providing enhanced support and navigation.
FDA-Cleared Indications
- Percutaneous catheter use within the vascular system, consistent with the FDA-cleared device labeling.
- Use as an access or delivery catheter during endovascular procedures when the catheter, accessories, and intended anatomy are compatible.
Clinical Applications
- Percutaneous vascular access and catheter delivery during endovascular procedures.
- Navigation through the venous circulation to support delivery of compatible interventional devices.
- Catheter support during procedures involving the iliac or central veins when use matches the device labeling and anatomy.
- Use with compatible aspiration or thrombectomy systems only when specifically permitted by the applicable labeling.
Reported off-label uses
- Use as an aspiration or distal-access catheter for mechanical thrombectomy in selected peripheral venous or arterial procedures outside the labeled indication.
- Use in neurointerventional thrombectomy or distal-access applications when the device is not specifically labeled for that anatomy or procedure.
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 11 studies, with a mix of randomized controlled trials and other study designs, spanning from 2023 to 2025. These studies explore various aspects of catheter use in clinical settings.
Reported Outcomes
Published studies report that the Sofia 88 Catheter improves reperfusion success in aspiration thrombectomy procedures. It is noted for its ability to provide additional support in complex vascular anatomies, potentially enhancing procedural outcomes.
Safety Profile
Reported complications include potential risks associated with catheter navigation in tortuous anatomy, such as vessel injury or distal embolization. However, specific safety data from the provided studies are limited.
Evidence Limitations
The current evidence is limited by a lack of large-scale, long-term studies specifically focused on the Sofia 88 Catheter. Further research is needed to establish comprehensive safety profiles and long-term efficacy outcomes.
Practical Considerations
- The catheter is a large-bore device; users should confirm inner diameter, outer diameter, usable length, and compatibility with guidewires, sheaths, aspiration tubing, and other accessories before use.
- Advance under appropriate fluoroscopic or other intravascular imaging guidance. Avoid excessive force, sharp bends, or advancement against resistance because these may cause vessel injury or catheter damage.
- MRI safety depends on the complete device configuration and the manufacturer's current labeling. Confirm MR conditions before scanning; do not assume the catheter is safe for MRI based only on its name.
- Contraindications and warnings include inability to obtain suitable vascular access, severe vessel tortuosity or stenosis that prevents safe passage, and known contraindications to the planned procedure, contrast, anticoagulation, or anesthesia.
- This is a single-use medical device and should not be resterilized or reused. Actual performance and procedural duration depend on anatomy, access, clot burden, and the other devices used.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for Sofia 88 Catheter?
The Sofia 88 Catheter is indicated for use in venous stenting procedures, particularly in mechanical thrombectomy for clot removal.
What outcomes have been reported in clinical studies?
Studies have reported improved reperfusion success and enhanced support in complex vascular anatomies during aspiration thrombectomy.
What complications have been reported?
Reported complications include potential vessel injury and distal embolization during catheter navigation.
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.