📊 Evidence-Based Reference
Guiding Catheter
Interventional Therapeutics
Summary: The guiding catheter by Interventional Therapeutics is a device used primarily in percutaneous coronary interventions. Key evidence highlights its efficacy in complex procedures such as chronic total occlusions.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K923518 ↗
Decision Date ?
January 12, 1993
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 January 12, 1993. It is manufactured by Interventional Therapeutics and classified as a Class 2 device.
What It Is
A guiding catheter is a flexible tube used to navigate and deliver interventional devices to target sites within the vascular system. It is primarily used in percutaneous coronary interventions to provide support and facilitate the delivery of therapeutic devices.
FDA-Cleared Indications
- Used for percutaneous introduction into the vascular system.
- Used to provide access and support for the delivery of interventional devices during vascular procedures.
- Intended for use under imaging guidance by trained clinicians.
Clinical Applications
- Providing vascular access and support during catheter-based interventions.
- Facilitating delivery of guidewires, balloons, stents, and other compatible devices.
- Supporting percutaneous treatment of vascular lesions when catheter guidance is required.
- Navigating through tortuous or complex vascular anatomy during an indicated endovascular procedure.
Reported off-label uses
- Use in selected venous interventions, including mechanical thrombectomy for deep vein thrombosis, when the catheter is compatible with the procedure and used according to institutional practice.
- Use as an access and support catheter during selected iliac or central venous stenting procedures.
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, comprising RCTs, prospective, and retrospective analyses, published between 2022 and 2024. These studies evaluate the efficacy and safety of guiding catheters in various interventional procedures.
Reported Outcomes
Published studies report that guiding catheters are effective in facilitating complex percutaneous coronary interventions, including chronic total occlusions. They provide necessary support and enable successful navigation and device delivery in challenging vascular anatomies.
Safety Profile
Reported complications include coronary artery perforation, which is a rare but serious risk during interventions. Other studies highlight the importance of proper catheter positioning to minimize adverse events.
Evidence Limitations
The evidence is limited by the lack of large-scale randomized controlled trials specifically focusing on guiding catheter outcomes. Further research is needed to explore long-term safety and efficacy in diverse patient populations.
Practical Considerations
- Catheter size, shaft length, tip shape, inner diameter, and support characteristics must be matched to the access vessel, target anatomy, guidewire, and therapeutic device.
- Use requires fluoroscopic or other appropriate imaging guidance, sterile technique, and continuous monitoring for vessel injury, bleeding, thrombosis, embolization, infection, or contrast-related complications.
- Compatibility with guidewires, balloons, stents, contrast media, and other devices should be confirmed in the manufacturer labeling before use.
- MRI safety is device-specific. Do not assume the catheter is MR safe or MR conditional unless the current product labeling identifies its MRI status; retained or damaged components may require additional assessment.
- The catheter is intended for a single procedure unless labeling specifically states otherwise. It is not a permanent implant and should be removed after the intervention.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for guiding catheter?
Guiding catheters are indicated for use in percutaneous coronary interventions, particularly in complex cases such as chronic total occlusions and challenging vascular anatomies.
What outcomes have been reported in clinical studies?
Studies have reported that guiding catheters are effective in supporting complex interventions, with successful navigation and device delivery in difficult cases.
What complications have been reported?
Safety data from evidence indicate complications such as coronary artery perforation and the need for careful catheter positioning to avoid adverse events.
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.