📊 Evidence-Based Reference
Asahi Zenyteex Guiding Catheter
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 ?
510(k)
Number ?
K091188 ↗
Decision Date ?
February 26, 2010
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Percutaneous catheter intended to access blood vessels and facilitate the delivery of interventional devices.
- Use is limited to the specific vessel-access, compatibility, and delivery indications in the current FDA-cleared labeling and instructions for use.
Clinical Applications
- Providing a vascular pathway for delivery of compatible interventional devices.
- Supporting catheter-based access during image-guided endovascular procedures.
- Navigating through the vasculature to a target treatment site when catheter support is required.
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.
Practical Considerations
- The available FDA summary does not specify the catheter's complete size range, working length, tip configuration, guidewire compatibility, or maximum injection pressure; users should consult the current manufacturer instructions for use.
- Compatibility with introducer sheaths, guidewires, contrast media, and other interventional devices must be confirmed before use.
- The procedure is typically performed through percutaneous vascular access under fluoroscopic or other appropriate imaging guidance, with local anesthesia and sedation as clinically indicated.
- Potential complications include vascular injury, bleeding or hematoma at the access site, thrombosis, embolization, infection, arrhythmia, contrast reaction, and loss of catheter integrity.
- MRI safety and conditional-use requirements are not established by the information provided here; check the current labeling before an MRI examination.
Procedures that use this device
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.