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acs tourgide guiding catheter
Advanced Cardiovascular Systems
Summary: The ACS TourGuide Guiding Catheter is a medical device used primarily in percutaneous coronary interventions. Key evidence highlights its role in facilitating access during procedures, with studies examining its use in various clinical scenarios.
FDA Clearance Information
Pathway
510K
Number
K953987 ↗
Decision Date
December 7, 1995
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The ACS TourGuide Guiding Catheter was cleared by the FDA through the 510(k) pathway on December 7, 1995. It is manufactured by Advanced Cardiovascular Systems and classified as a Class 2 device.
What It Is
The ACS TourGuide Guiding Catheter is designed to provide support and facilitate the delivery of interventional devices during percutaneous coronary interventions. It is used to navigate through the vascular system to reach coronary arteries.
Clinical Applications
Commonly used in procedures such as percutaneous coronary interventions, the ACS TourGuide Guiding Catheter assists in accessing coronary arteries, particularly in acute coronary syndrome cases where precise catheter placement is critical.
Evidence Summary
The literature includes six studies, ranging from 2020 to 2023, encompassing various study types such as RCTs and retrospective analyses. These studies explore the catheter's application in different clinical settings.
Reported Outcomes
Published studies report that the ACS TourGuide Guiding Catheter is effective in facilitating access during percutaneous coronary interventions, with particular benefits noted in acute coronary syndrome cases. The catheter's design supports successful navigation and placement in challenging vascular anatomies.
Safety Profile
Reported complications include access-site complications, particularly in transradial procedures. However, the overall safety profile is consistent with other guiding catheters used in similar clinical scenarios.
Evidence Limitations
The evidence is limited by the small number of studies directly focusing on the ACS TourGuide Guiding Catheter. Further research is needed to explore long-term outcomes and compare its efficacy and safety with newer catheter designs.
Frequently Asked Questions
What are the clinical indications for ACS TourGuide Guiding Catheter?
The ACS TourGuide Guiding Catheter is indicated for use in percutaneous coronary interventions, particularly in cases of acute coronary syndrome.
What outcomes have been reported in clinical studies?
Studies have reported effective access facilitation during procedures, with benefits in acute coronary syndrome cases.
What complications have been reported?
Safety data indicate access-site complications, especially in transradial procedures, but overall safety is comparable to other guiding catheters.
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.