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asahi zenyteex guiding catheter
Asahi Intecc
Summary: The Asahi Zenyteex Guiding Catheter is a device used primarily in venous stenting procedures. It is designed to facilitate the delivery of interventional devices to the target site. Key evidence highlights its efficacy in complex percutaneous coronary interventions.
FDA Clearance Information
Pathway
510K
Number
K091188 ↗
Decision Date
February 26, 2010
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Asahi Zenyteex Guiding Catheter was cleared by the FDA through the 510(k) pathway on February 26, 2010. Manufactured by Asahi Intecc, it is classified as a Class 2 device.
What It Is
The Asahi Zenyteex Guiding Catheter is a medical device used to guide interventional tools to the site of a venous stent placement. It is designed to provide support and stability during procedures, facilitating the delivery of therapeutic devices.
Clinical Applications
This guiding catheter is commonly used in procedures involving venous stents, particularly in complex percutaneous coronary interventions. It is utilized in scenarios where precise navigation and support are required to access challenging vascular sites.
Evidence Summary
The available literature includes 10 studies, comprising randomized controlled trials, prospective and retrospective analyses, and case series, spanning from 2022 to 2025. These studies evaluate the efficacy and safety of the catheter in various clinical settings.
Reported Outcomes
Published studies report that the Asahi Zenyteex Guiding Catheter is effective in facilitating complex percutaneous coronary interventions, particularly in challenging anatomical scenarios. The catheter's design allows for improved navigation and support, contributing to successful procedural outcomes.
Safety Profile
Reported complications include potential radial trauma when used in transradial access, as noted in studies evaluating sheathless guiding systems. Overall, the catheter is considered safe with a low incidence of adverse events.
Evidence Limitations
Current evidence is limited by the small sample sizes and the lack of long-term follow-up data in some studies. Further research is needed to evaluate the catheter's performance in diverse patient populations and complex clinical scenarios.
Frequently Asked Questions
What are the clinical indications for Asahi Zenyteex Guiding Catheter?
The Asahi Zenyteex Guiding Catheter is indicated for use in venous stenting procedures, particularly in complex percutaneous coronary interventions.
What outcomes have been reported in clinical studies?
Studies have reported successful procedural outcomes in complex percutaneous coronary interventions, with improved navigation and support provided by the catheter.
What complications have been reported?
Safety data from evidence indicate potential radial trauma in transradial access, though overall adverse events are low.
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.