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edwards esheath introducer set
Edwards Lifesciences
Summary: The Edwards eSheath Introducer Set is a medical device used to facilitate the insertion of catheters and other devices into the vascular system. It is primarily used by interventional cardiologists and radiologists in procedures such as transcatheter aortic valve replacement (TAVR).
FDA Clearance Information
Pathway
510K
Number
K152225 ↗
Decision Date
November 24, 2015
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Edwards eSheath Introducer Set was cleared through the FDA 510(k) pathway on November 24, 2015. Manufactured by Edwards Lifesciences, it is classified as a Class 2 device under product code DYB.
What It Is
The Edwards eSheath Introducer Set is a specialized introducer sheath designed to provide a conduit for the insertion of catheters and other medical devices into the vascular system. It features a flexible design that minimizes trauma to the vessel wall during insertion and removal. The device is particularly useful in procedures requiring large-bore access, such as transcatheter aortic valve replacement (TAVR), where it facilitates the smooth passage of the valve delivery system.
Clinical Applications
This device is commonly used in interventional cardiology and radiology, particularly in procedures like TAVR, where large-bore vascular access is necessary. It is often employed in catheterization labs and hybrid operating rooms. The introducer set is suitable for adult patients undergoing minimally invasive cardiac procedures, especially those with aortic stenosis requiring valve replacement.
Indications for Use
The FDA indications for the Edwards eSheath Introducer Set include its use in facilitating the insertion of catheters and other devices into the vascular system. It is intended for patients undergoing procedures that require large-bore access, such as TAVR.
Practical Considerations
The Edwards eSheath Introducer Set is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with a range of catheter-based devices. Clinicians should be familiar with the insertion technique to minimize vascular trauma and ensure optimal outcomes.
Related Literature
The J-Valve Transfemoral Pivotal Study investigated the use of the Edwards eSheath Introducer Set in the context of transfemoral valve replacement procedures. Although specific details and findings are not available, such studies typically assess the safety and efficacy of the device in facilitating valve delivery. Limitations may include a lack of long-term outcome data and a focus on specific patient populations.
Frequently Asked Questions
What is the Edwards eSheath Introducer Set used for?
It is used to facilitate the insertion of catheters and other devices into the vascular system, particularly in procedures like TAVR.
What specialties typically use this device?
Interventional cardiologists and radiologists primarily use this device.
What are the FDA-cleared indications?
It is indicated for facilitating the insertion of catheters and devices into the vascular system, especially in procedures requiring large-bore access.
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.