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sofia 6f catheter
Microvention
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
510K
Number
K150366 ↗
Decision Date
March 27, 2015
Product Code
DQY
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.
Clinical Applications
The Sofia 6F catheter is commonly used in acute ischemic stroke interventions, where it serves as an aspiration catheter. It can also function as an intermediate catheter when a stent retriever is needed.
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.
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.