📊 Evidence-Based Reference
Advance Cs Coronary Sinus Infusion Catheter
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 ?
510(k)
Number ?
K131204 ↗
Decision Date ?
January 29, 2014
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Infusion of fluids or medications into the coronary sinus during percutaneous cardiac procedures.
- Use as a percutaneous catheter for vascular access and infusion under imaging guidance.
Clinical Applications
- Selective catheterization and infusion within the coronary sinus.
- Delivery of an infused agent during procedures involving the vein of Marshall when the vessel can be accessed.
- Use during interventional cardiac procedures requiring targeted venous infusion.
Reported off-label uses
- Ethanol infusion into the vein of Marshall as part of an atrial fibrillation ablation strategy, when performed outside the device's specific cleared labeling or institutional protocol.
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 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.
Practical Considerations
- The catheter is intended for percutaneous vascular use and should be handled with fluoroscopic or other appropriate imaging guidance.
- Access, catheter size, usable length, and compatibility with guidewires, contrast media, and infusion equipment should be confirmed in the current Cook instructions for use.
- Because this catheter is used in the coronary venous system, risks include vessel injury, perforation, bleeding, thrombosis, arrhythmia, infection, and complications related to the infused agent.
- MRI safety and conditions depend on the exact model and configuration; consult the current labeling rather than assuming the catheter is MR safe.
- Contraindications, warnings, and infusion limits should be reviewed in the current FDA-cleared labeling before use.
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.