đź“Š Evidence-Based Reference
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 ?
510(k)
Number ?
K853998 ↗
Decision Date ?
November 6, 1985
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Used as a percutaneous catheter for access to the vascular system during an interventional procedure, according to the applicable FDA-cleared labeling.
- Used to facilitate the placement or delivery of compatible interventional devices to a selected vascular site when specified by the product labeling.
Clinical Applications
- Percutaneous vascular access and catheter-based intervention when the device labeling identifies the target vessel and procedure.
- Providing a conduit and support for compatible catheters, wires, or other interventional devices.
- Navigation through selected vascular anatomy under imaging guidance, when included in the device-specific instructions for use.
Reported off-label uses
- Support catheter for complex endovascular procedures, including selected chronic total occlusion interventions, when the treating physician determines that off-label use is appropriate.
- Guide or support catheter in selected neuroendovascular procedures, when the specific catheter design and labeling are suitable.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
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.
Practical Considerations
- Catheter size, length, tip shape, lumen diameter, and stiffness must match the access vessel, target anatomy, guidewire, and devices being used.
- Use fluoroscopy or other appropriate imaging guidance and follow the manufacturer's instructions for preparation, advancement, flushing, and device compatibility.
- The FDA record provided does not establish a universal MRI safety status; MRI conditions must be confirmed in the current product labeling.
- Potential complications include vascular injury, bleeding, thrombosis, embolization, infection, contrast reaction, arrhythmia, and vessel spasm.
- Contraindications and warnings are product-specific; do not use a catheter with incompatible devices or advance it against significant resistance.
Procedures that use this device
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.