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ptca guiding catheter
Cordis
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
510K
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.
Clinical Applications
Commonly used in coronary angioplasty, the PTCA guiding catheter assists in the placement of stents and other therapeutic devices within coronary arteries. It is integral in procedures requiring precise navigation and device delivery.
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.
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.