📊 Evidence-Based Reference
Coronary Guiding Catheter-Modified
Advanced Cardiovascular Systems
Summary: The coronary guiding catheter-modified by Advanced Cardiovascular Systems is used in percutaneous coronary interventions. Key evidence highlights its role in improving clinical outcomes when used with quantitative flow ratio guidance.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K831563 ↗
Decision Date ?
June 30, 1983
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The coronary guiding catheter-modified was cleared by the FDA through the 510(k) pathway on June 30, 1983. It is manufactured by Advanced Cardiovascular Systems and classified as a Class 2 device.
What It Is
The coronary guiding catheter-modified is a medical device designed to facilitate the delivery of interventional devices to the coronary vasculature. It is primarily used in percutaneous coronary interventions to provide support and guide wires and catheters to the target site.
FDA-Cleared Indications
- Used to facilitate percutaneous catheter-based procedures by providing access to and support within the cardiovascular system.
- Used to guide or deliver interventional devices during procedures involving the coronary vasculature, according to the applicable device labeling.
Clinical Applications
- Providing a pathway and backup support for guidewires during coronary catheter-based interventions.
- Facilitating delivery of balloon catheters, stents, and other interventional devices to a coronary target.
- Supporting selective catheterization and contrast injection during diagnostic or interventional coronary angiography.
- Helping maintain catheter position during percutaneous coronary intervention when device support is needed.
Reported off-label uses
- Use in selected peripheral vascular interventions when a guiding catheter with similar support and lumen characteristics is appropriate; this is off-label unless specifically cleared for the intended anatomy and procedure.
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 15 studies, encompassing randomized controlled trials and other study designs, published between 2022 and 2024. These studies explore various aspects of coronary interventions, including the use of guiding catheters.
Reported Outcomes
Published studies report that the use of guiding catheters in conjunction with quantitative flow ratio guidance can improve clinical outcomes in coronary interventions. The FAVOR III China trial demonstrated enhanced 1-year outcomes compared to conventional angiographic guidance.
Safety Profile
Reported complications include potential for vessel trauma or dissection during catheter manipulation. However, specific safety data from the provided studies are limited.
Evidence Limitations
The evidence is limited by a lack of detailed safety outcomes and long-term efficacy data. Further research is needed to explore the full range of clinical scenarios and patient populations that may benefit from this device.
Practical Considerations
- The record does not specify the catheter's French sizes, working length, curve configuration, lumen diameter, or compatible guidewire and delivery-system dimensions; these must be confirmed in the product labeling.
- Use requires fluoroscopic or other appropriate imaging guidance, sterile technique, and an access route selected for the planned procedure, commonly femoral or radial arterial access for coronary work.
- Inspect the catheter before use and avoid excessive force, sharp bends, or advancing against resistance because these actions can cause kinking, thrombosis, vessel injury, or device damage.
- MRI safety is model-specific. Do not assume the catheter is MR Safe or MR Conditional; review the current labeling before MRI, and do not leave an indwelling catheter in place unless its labeling permits it.
- Potential complications include bleeding or hematoma at the access site, arterial injury, dissection, perforation, thrombosis, embolization, infection, arrhythmia, contrast reaction, and kidney injury related to the overall procedure.
Frequently Asked Questions
What are the clinical indications for coronary guiding catheter-modified?
The device is indicated for use in percutaneous coronary interventions to facilitate the delivery of interventional devices to the coronary vasculature.
What outcomes have been reported in clinical studies?
Studies report improved clinical outcomes with the use of guiding catheters and quantitative flow ratio guidance in coronary interventions.
What complications have been reported?
Reported complications include potential vessel trauma or dissection during catheter manipulation.
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.