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guiding catheter
Target Therapeutics
Summary: The guiding catheter by Target Therapeutics is used primarily in percutaneous coronary interventions. Key evidence highlights its efficacy and safety in complex procedures, including chronic total occlusions.
FDA Clearance Information
Pathway
510K
Number
K853998 ↗
Decision Date
November 6, 1985
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The guiding catheter was cleared by the FDA through the 510(k) pathway on November 6, 1985. It is manufactured by Target Therapeutics and classified as a Class 2 device.
What It Is
A guiding catheter is a medical device used to facilitate the delivery of interventional devices to target sites within the vascular system. It is primarily used in procedures such as percutaneous coronary interventions.
Clinical Applications
Guiding catheters are commonly used in coronary and neuroendovascular procedures, particularly in scenarios requiring precise navigation through complex vascular anatomies, such as chronic total occlusions and carotid artery access.
Evidence Summary
The literature includes 15 studies, ranging from randomized controlled trials to case series, published between 2022 and 2024. These studies explore various applications and techniques involving guiding catheters.
Reported Outcomes
Published studies report that guiding catheters are effective in facilitating complex percutaneous coronary interventions, including those with chronic total occlusions. The use of guiding catheter extensions has been shown to enhance procedural success in challenging cases.
Safety Profile
Reported complications include iatrogenic coronary perforation and issues related to catheter advancement in difficult anatomies. However, techniques such as the balloon-trapping method have been developed to mitigate these risks.
Evidence Limitations
Current evidence is limited by a lack of large-scale randomized controlled trials specifically focused on guiding catheter safety and efficacy. Further research is needed to better understand long-term outcomes and optimize procedural techniques.
Frequently Asked Questions
What are the clinical indications for guiding catheters?
Guiding catheters are indicated for use in percutaneous coronary interventions and neuroendovascular procedures, particularly in complex vascular anatomies.
What outcomes have been reported in clinical studies?
Studies have reported successful facilitation of complex interventions, including chronic total occlusions, with guiding catheters.
What complications have been reported?
Safety data indicate complications such as coronary perforation and challenges in catheter advancement, with techniques available to address these issues.
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.