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coronary guiding catheter
Advanced Cardiovascular Systems
Summary: The coronary guiding catheter by Advanced Cardiovascular Systems is used in coronary interventions to facilitate the delivery of interventional devices. Key evidence highlights its role in influencing coronary hemodynamics and procedural outcomes.
FDA Clearance Information
Pathway
510K
Number
K830829 ↗
Decision Date
April 28, 1983
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The coronary guiding catheter was cleared by the FDA through the 510(k) pathway on April 28, 1983. It is manufactured by Advanced Cardiovascular Systems and is classified as a Class 2 device.
What It Is
The coronary guiding catheter is a medical device used in percutaneous coronary interventions (PCI) to provide a conduit for other interventional devices to reach coronary arteries. It is designed to facilitate the delivery and support of guidewires and other devices during coronary angiography and interventions.
Clinical Applications
Commonly used in procedures such as coronary angioplasty and stent placement, the coronary guiding catheter is essential for accessing coronary arteries and delivering therapeutic devices. It is particularly useful in complex coronary interventions requiring precise navigation and support.
Evidence Summary
The literature includes 15 studies, encompassing various study types such as RCTs, prospective, and retrospective studies, with publication years ranging from 2023 to 2025. These studies explore the catheter's impact on coronary hemodynamics and procedural outcomes.
Reported Outcomes
Published studies report that the coronary guiding catheter can influence flow and pressure measurements during invasive coronary angiography. It has been shown to aid in the visualization of device endothelialization and impact coronary hemodynamics in experimental models.
Safety Profile
Reported complications include potential alterations in coronary flow dynamics during catheter use. No specific adverse events were detailed in the provided studies, but the impact on hemodynamics suggests a need for careful procedural monitoring.
Evidence Limitations
The evidence is limited by the small number of studies directly assessing the catheter's safety and efficacy. Further research is needed to explore long-term outcomes and potential complications in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for coronary guiding catheter?
The coronary guiding catheter is indicated for use in coronary angiography and percutaneous coronary interventions to facilitate the delivery of interventional devices.
What outcomes have been reported in clinical studies?
Studies report that the catheter can affect coronary hemodynamics and aid in procedural success during coronary interventions.
What complications have been reported?
Reported complications include potential changes in coronary flow dynamics, necessitating careful monitoring during use.
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.