📊 Evidence-Based Reference
Coronary Infusion Catheter
Advanced Cardiovascular Systems
Summary: The coronary infusion catheter by Advanced Cardiovascular Systems is used for local drug delivery in coronary interventions. Key evidence highlights its role in reducing restenosis rates with heparin delivery.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K831717 ↗
Decision Date ?
June 30, 1983
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The coronary infusion catheter was cleared through the FDA 510(k) pathway on June 30, 1983. Manufactured by Advanced Cardiovascular Systems, it is classified as a Class 2 device.
What It Is
The coronary infusion catheter is designed for the localized delivery of therapeutic agents directly into coronary arteries. It is primarily used in interventional cardiology to deliver drugs like heparin to prevent restenosis.
FDA-Cleared Indications
- Percutaneous catheter use for diagnostic or therapeutic procedures in the vascular system, consistent with FDA product code DQY.
- Delivery of fluids or therapeutic agents through a catheter positioned in a blood vessel when indicated by the treating physician.
Clinical Applications
- Catheter-based delivery of a therapeutic agent to a selected vascular location.
- Use during percutaneous coronary interventions when localized infusion is clinically indicated.
- Infusion through a catheter under fluoroscopic or other appropriate imaging guidance.
Reported off-label uses
- Localized delivery of anticoagulant or thrombolytic medication in selected coronary interventions.
- Local delivery of other investigational or physician-selected medications in vascular research or specialized clinical practice.
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 literature includes 10 studies, comprising randomized controlled trials and case series, spanning from 1994 to 2019. These studies explore the catheter's efficacy in drug delivery for coronary interventions.
Reported Outcomes
Published studies report that local heparin delivery using the coronary infusion catheter can reduce target vessel revascularization rates to 28.26%. However, other studies, such as those involving S-dC28, did not show significant prevention of restenosis.
Safety Profile
Reported complications include a 19.15% incidence of ischemia and one reported death occurring six days post-intervention. These highlight the need for careful patient monitoring during and after procedures.
Evidence Limitations
The evidence is limited by small sample sizes and variability in study designs. Further research is needed to confirm long-term efficacy and safety across diverse patient populations.
Practical Considerations
- The available FDA record does not provide a complete size range, lumen dimensions, maximum pressure, or guidewire-compatibility specifications; these must be confirmed in the applicable device labeling.
- Use requires vascular access, appropriate imaging guidance, and compatibility with the planned guidewire, sheath, contrast, infusion solution, and other procedural equipment.
- Potential complications include bleeding or hematoma at the access site, vessel injury, thrombosis, embolization, infection, arrhythmia, allergic reaction, and coronary ischemic events.
- MRI safety is not established by the information provided. Confirm the exact device labeling and MRI conditions before an MRI examination.
- The catheter is a single-use interventional device; it is not intended to remain permanently implanted, and its usable duration is limited to the procedure unless the labeling states otherwise.
Frequently Asked Questions
What are the clinical indications for coronary infusion catheter?
The device is indicated for local drug delivery in coronary arteries, particularly to prevent restenosis post-angioplasty.
What outcomes have been reported in clinical studies?
Studies have shown a reduction in target vessel revascularization rates with heparin delivery, though not all agents tested have been effective.
What complications have been reported?
Safety data indicate a 19.15% incidence of ischemia and a case of post-procedural death, necessitating careful monitoring.
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.