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sheathless eaucath coronary guide catheter
Asahi Intecc
Summary: The sheathless Eaucath is a coronary guide catheter used primarily for transradial coronary interventions. Key evidence highlights its effectiveness in overcoming severe radial spasm.
FDA Clearance Information
Pathway
510K
Number
K132556 ↗
Decision Date
October 24, 2013
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The sheathless Eaucath coronary guide catheter was cleared by the FDA via the 510(k) pathway on October 24, 2013. It is manufactured by Asahi Intecc and classified as a Class 2 device.
What It Is
The sheathless Eaucath is a coronary guide catheter designed for use in percutaneous coronary interventions (PCI). It allows for catheterization without the need for an introducer sheath, reducing the diameter of arterial access.
Clinical Applications
Commonly used in transradial coronary interventions, the sheathless Eaucath is particularly beneficial in cases of severe radial artery spasm and when minimizing access site complications is critical.
Evidence Summary
The literature includes 10 studies, comprising randomized controlled trials, prospective and retrospective analyses, and case series, conducted between 2019 and 2023.
Reported Outcomes
Published studies report that the sheathless Eaucath is effective in overcoming severe radial spasm and provides a viable alternative to traditional sheath-based systems. It has been shown to maintain lumen diameter while reducing access site complications.
Safety Profile
Reported complications include radial artery spasm and potential access site complications, though these are generally less frequent compared to traditional sheath systems.
Evidence Limitations
Current evidence is limited by the small sample sizes and the need for more randomized controlled trials to confirm long-term efficacy and safety. Further research is needed to explore its use in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for sheathless Eaucath?
The sheathless Eaucath is indicated for use in percutaneous coronary interventions, particularly in cases requiring reduced access site diameter and in overcoming severe radial spasm.
What outcomes have been reported in clinical studies?
Clinical studies have reported the sheathless Eaucath's effectiveness in reducing radial artery spasm and minimizing access site complications.
What complications have been reported?
Safety data indicate that complications can include radial artery spasm and access site issues, though these are less frequent compared to traditional systems.
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.