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edwards esheath introducer set
Edward Lifesciences
Summary: The Edwards eSheath Introducer Set is a medical device used for vascular access during procedures like transcatheter aortic valve replacement (TAVR). It is primarily used by interventional cardiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K162184 ↗
Decision Date
September 2, 2016
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Edwards eSheath Introducer Set was cleared through the FDA 510(k) pathway on September 2, 2016. It is manufactured by Edward Lifesciences and classified as a Class 2 device under product code DYB.
What It Is
The Edwards eSheath Introducer Set is a specialized device designed to facilitate the insertion of larger catheters or devices into the vascular system. It features a flexible, expandable sheath that minimizes vascular trauma during insertion and removal. This device is particularly useful in procedures requiring precise vascular access, such as transcatheter aortic valve replacement (TAVR).
Clinical Applications
The eSheath Introducer Set is commonly used in interventional cardiology and vascular surgery. It is particularly valuable in procedures like TAVR, where large-bore access is necessary. The device is used in hospital settings, primarily in catheterization labs or hybrid operating rooms, and is suitable for adult patients undergoing complex cardiovascular interventions.
Indications for Use
The FDA indications for the Edwards eSheath Introducer Set include its use in facilitating vascular access for procedures requiring large-bore catheterization. It is intended for patients undergoing interventions such as TAVR, where traditional access methods may be inadequate.
Practical Considerations
The Edwards eSheath 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 complications.
Related Literature
The J-Valve Transfemoral Pivotal Study investigated the use of the Edwards eSheath Introducer Set in transfemoral procedures. While specific details and findings are not available, the study likely focused on the safety and efficacy of the device in facilitating vascular access. Limitations include the lack of an abstract and detailed results, which restricts comprehensive analysis.
Frequently Asked Questions
What is the Edwards eSheath Introducer Set used for?
It is used for providing vascular access during procedures like transcatheter aortic valve replacement (TAVR).
What specialties typically use this device?
Interventional cardiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for facilitating vascular access in procedures requiring large-bore catheterization, such as TAVR.
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.