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guiding catheter
Centerpoint Systems
Summary: The guiding catheter by Centerpoint Systems is used primarily in neuroendovascular and coronary interventions. Key evidence highlights its efficacy in complex procedures such as PCI and CTO recanalization.
FDA Clearance Information
Pathway
510K
Number
K210009 ↗
Decision Date
November 24, 2021
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The guiding catheter by Centerpoint Systems was cleared via the FDA 510(k) pathway on November 24, 2021. It is classified as a Class 2 device under product code DQY.
What It Is
The guiding catheter is a medical device used to facilitate the delivery of interventional tools during procedures such as percutaneous coronary intervention (PCI) and neuroendovascular therapy. It is designed to provide support and stability for the advancement of other catheters or devices to the target site.
Clinical Applications
Guiding catheters are commonly used in procedures involving the coronary and carotid arteries, particularly in complex cases such as chronic total occlusions and transradial coronary interventions. They are essential for ensuring precise delivery and positioning of interventional devices.
Evidence Summary
The literature includes 15 studies, encompassing randomized controlled trials, prospective and retrospective studies, and case series, published between 2022 and 2024. These studies evaluate the efficacy and safety of guiding catheters in various clinical scenarios.
Reported Outcomes
Published studies report that guiding catheters are effective in facilitating complex coronary and neuroendovascular procedures. They provide essential support for interventions such as PCI and CTO recanalization, improving procedural success rates. The use of sheathless guiding systems has been shown to enhance safety and efficacy in transradial approaches.
Safety Profile
Reported complications include iatrogenic coronary perforation and issues related to catheter positioning. However, techniques such as the double-guiding catheter and balloon-trapping have been developed to mitigate these risks.
Evidence Limitations
Current evidence is limited by the lack of large-scale randomized trials directly comparing different guiding catheter systems. Further research is needed to establish long-term outcomes and optimize catheter design for specific clinical scenarios.
Frequently Asked Questions
What are the clinical indications for guiding catheter?
Guiding catheters are indicated for use in coronary and neuroendovascular interventions, including PCI and carotid artery procedures.
What outcomes have been reported in clinical studies?
Studies report improved procedural success rates in complex interventions, with effective support provided for PCI and CTO recanalization.
What complications have been reported?
Safety data indicate risks of coronary perforation and catheter positioning issues, though mitigation techniques 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.