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Ptca Guiding Catheter
Summary: The PTCA guiding catheter by Cordis is a device used in percutaneous transluminal coronary angioplasty. Key evidence highlights its efficacy in coronary interventions with high engagement and stent delivery success rates.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K851947 ↗
Decision Date ?
August 16, 1985
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The PTCA guiding catheter was cleared by the FDA through the 510(k) pathway on August 16, 1985. It is manufactured by Cordis and classified as a Class 2 device.
What It Is
The PTCA guiding catheter is designed for use in percutaneous transluminal coronary angioplasty procedures. It facilitates the delivery of interventional devices to coronary arteries, aiding in the treatment of coronary artery disease.
FDA-Cleared Indications
- Used to facilitate percutaneous transluminal coronary angioplasty of the coronary arteries.
- Used as a guiding conduit for the introduction and positioning of compatible interventional devices in the coronary vasculature.
Clinical Applications
- Guiding balloon angioplasty during coronary artery intervention.
- Providing access for delivery of coronary stents.
- Supporting placement of other compatible therapeutic devices in the coronary arteries.
- Selective catheterization and angiographic visualization of coronary arteries during an intervention.
Evidence Summary
The literature includes 12 studies, comprising case reports and series, with publication years ranging from 1998 to 2025. These studies evaluate the catheter's efficacy and safety in various clinical settings.
Reported Outcomes
Published studies report high engagement rates with the PTCA guiding catheter, achieving up to 96% with modifications. Stent delivery success rates are noted at 98.4%, with successful engagement in both coronary arteries in 89% of cases.
Safety Profile
Reported complications include two instances of dislodged stents and four cases of non-Q wave myocardial infarction. No major cardiac or entry site-related complications were observed, and no vascular surgery or blood transfusions were required.
Evidence Limitations
The evidence is limited by the small sample sizes and the retrospective nature of some studies. Further research is needed to evaluate long-term outcomes and compare the catheter's performance with newer devices.
Practical Considerations
- The catheter is selected by its French size, shaft length, tip shape, support characteristics, and compatibility with the intended guidewire or interventional device.
- It is commonly introduced through femoral or radial arterial access and advanced under fluoroscopic guidance; the access route depends on patient anatomy and operator judgment.
- The catheter must be flushed, connected to compatible hemostasis and contrast systems, and used according to the manufacturer’s labeling to reduce the risk of air embolism, clot formation, or vessel injury.
- MRI safety depends on the exact model and whether the catheter remains in the patient. The product-specific labeling should be checked before MRI; a catheter used only during a procedure is generally removed before scanning.
- Potential complications include coronary dissection or perforation, spasm, thrombosis, embolization, bleeding at the access site, arrhythmia, allergic reaction to contrast, and kidney injury. It is not used when coronary catheterization or the planned intervention is contraindicated.
Frequently Asked Questions
What are the clinical indications for PTCA guiding catheter?
The PTCA guiding catheter is indicated for use in percutaneous transluminal coronary angioplasty to facilitate the delivery of interventional devices to coronary arteries.
What outcomes have been reported in clinical studies?
Clinical studies report high engagement and stent delivery success rates, with engagement rates reaching 96% and stent delivery success at 98.4%.
What complications have been reported?
Safety data indicate complications such as dislodged stents and non-Q wave myocardial infarction, but no major cardiac or entry site-related complications were reported.
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.