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advance cs coronary sinus infusion catheter
Cook
Summary: The Advance CS Coronary Sinus Infusion Catheter by Cook is designed for infusion into the coronary sinus. It is primarily used in procedures involving the vein of Marshall. Key evidence highlights its utility in enhancing ethanol infusion in non-visualized veins.
FDA Clearance Information
Pathway
510K
Number
K131204 ↗
Decision Date
January 29, 2014
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Advance CS Coronary Sinus Infusion Catheter was cleared by the FDA through the 510(k) pathway on January 29, 2014. It is manufactured by Cook and classified as a Class 2 device.
What It Is
The Advance CS Coronary Sinus Infusion Catheter is a medical device used for infusions into the coronary sinus, particularly in procedures involving the vein of Marshall. It facilitates targeted delivery of therapeutic agents in cardiac interventions.
Clinical Applications
This catheter is commonly used in cardiac procedures requiring infusion into the coronary sinus, such as ethanol infusion for arrhythmia management. It is particularly useful in cases where the vein of Marshall is not easily visualized.
Evidence Summary
The available literature includes six studies, comprising various study types such as RCTs and case series, conducted between 2021 and 2025. These studies explore the catheter's utility in enhancing ethanol infusion and its effects on myocardial blood flow.
Reported Outcomes
Published studies report that the Advance CS Catheter effectively enhances ethanol infusion in the vein of Marshall, improving procedural outcomes in arrhythmia management. It has been shown to facilitate myocardial blood flow measurements and aid in assessing stress adequacy during cardiac interventions.
Safety Profile
Reported complications include coronary arterial vasospasm following ethanol infusion, as observed in a case study. Other studies did not report significant adverse events, indicating a generally favorable safety profile.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of large-scale randomized controlled trials. Further research is needed to fully understand the long-term safety and efficacy of the device in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Advance CS Coronary Sinus Infusion Catheter?
The catheter is indicated for use in procedures requiring infusion into the coronary sinus, particularly for managing arrhythmias involving the vein of Marshall.
What outcomes have been reported in clinical studies?
Studies have reported improved ethanol infusion utility and enhanced myocardial blood flow measurements during cardiac interventions.
What complications have been reported?
Safety data indicate that coronary arterial vasospasm is a potential complication following ethanol infusion, though other significant adverse events have not been widely reported.
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.