đź“‹ FDA Reference
edwards esheath introducer set
Edwards Lifesciences
Summary: The Edwards eSheath Introducer Set is a medical device used to facilitate the introduction of catheters and other devices into the vascular system. It is primarily used by interventional cardiologists and radiologists during procedures like transcatheter aortic valve replacement (TAVR).
FDA Clearance Information
Pathway
510K
Number
K141696 ↗
Decision Date
September 18, 2014
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Edwards eSheath Introducer Set was cleared through the FDA 510k pathway on September 18, 2014. 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 medical device designed to provide vascular access for the introduction of catheters and other interventional tools. It features a flexible, expandable sheath that accommodates various device sizes while minimizing trauma to the vessel. This design is particularly beneficial in procedures requiring precise access and navigation within the vascular system.
Clinical Applications
Commonly used in interventional cardiology and radiology, the Edwards eSheath Introducer Set is essential in procedures like transcatheter aortic valve replacement (TAVR) and other catheter-based interventions. It is suitable for use in hospital settings, particularly in catheterization labs, and is designed for adult patients requiring vascular access for complex interventions.
Indications for Use
The device is indicated for use in patients requiring vascular access for the delivery of catheters and other interventional devices. It is particularly useful in procedures involving the heart and large blood vessels, such as TAVR.
Practical Considerations
The eSheath is available in multiple sizes to accommodate different patient anatomies and procedural needs. It is compatible with a range of catheters and interventional devices, and its expandable design helps reduce vessel trauma during insertion and removal.
Related Literature
The J-Valve Transfemoral Pivotal Study investigated the use of the J-Valve system, which likely involved the Edwards eSheath Introducer Set as part of the procedure. While specific details and findings are not available, such studies typically assess the safety and efficacy of new valve systems in patients undergoing TAVR. Limitations include the lack of available data and specific outcomes from the study.
Frequently Asked Questions
What is the Edwards eSheath Introducer Set used for?
It is used to provide vascular access for the introduction of catheters and interventional devices during procedures like TAVR.
What specialties typically use this device?
Interventional cardiologists and radiologists primarily use this device in catheterization labs.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring vascular access for catheter-based interventions, particularly in the heart and large blood vessels.
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.