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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
510K
Number
K831563 ↗
Decision Date
June 30, 1983
Product Code
DQY
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.
Clinical Applications
This device is commonly used in scenarios requiring precise navigation and support during coronary interventions, such as in patients with complex coronary artery disease or after transcatheter aortic valve replacement.
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.
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.