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guiding catheter
Texasmedical Technologies
Summary: The guiding catheter by Texasmedical Technologies is used primarily for vascular access in procedures like PCI. Key evidence highlights its efficacy in complex interventions and safety in various approaches.
FDA Clearance Information
Pathway
510K
Number
K153703 ↗
Decision Date
May 12, 2016
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The guiding catheter was cleared via the FDA 510(k) pathway on May 12, 2016. Manufactured by Texasmedical Technologies, it is classified as a Class 2 device.
What It Is
A guiding catheter is a medical device used to facilitate the placement of other devices within the vascular system. It is primarily used in interventional cardiology and radiology to provide support and direction for catheters and wires during procedures.
Clinical Applications
Guiding catheters are commonly used in percutaneous coronary interventions (PCI) and neuroendovascular therapies. They are essential in accessing difficult vascular anatomies and supporting device delivery in complex cases.
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 the efficacy of guiding catheters in facilitating complex PCI, particularly in chronic total occlusions and distal radial access. They are noted for improving procedural success rates and enabling advanced techniques like the double-guiding catheter method.
Safety Profile
Reported complications include coronary artery perforation and challenges in catheter positioning. However, techniques such as the balloon-trapping method have been developed to mitigate risks like detached catheter tips.
Evidence Limitations
Current evidence lacks large-scale randomized trials specifically focusing on long-term outcomes and safety profiles. Further research is needed to explore the comparative effectiveness of different guiding catheter designs and techniques.
Frequently Asked Questions
What are the clinical indications for guiding catheter?
Guiding catheters are indicated for use in vascular access during procedures such as PCI and neuroendovascular therapies, particularly in complex anatomical scenarios.
What outcomes have been reported in clinical studies?
Studies have reported improved procedural success in complex PCI and effective use in distal radial access, with techniques like the double-guiding catheter method enhancing outcomes.
What complications have been reported?
Safety data indicate risks such as coronary artery perforation and catheter tip detachment, though mitigation strategies like the balloon-trapping technique are available.
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.