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sofia 88 catheter
Microvention
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
510K
Number
K214024 ↗
Decision Date
September 12, 2022
Product Code
DQY
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.
Clinical Applications
Commonly used in mechanical thrombectomy procedures, the Sofia 88 Catheter assists in navigating tortuous vascular anatomy. It is particularly beneficial in cases requiring aspiration catheter delivery for clot removal.
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.
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.