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edwards esheath optima introducer set
Edwards Lifesciences
Summary: The Edwards eSheath Optima Introducer Set is a medical device used primarily in interventional cardiology for the introduction of catheters and other devices into the vascular system. It is typically used by cardiologists during procedures such as transcatheter aortic valve replacement (TAVR).
FDA Clearance Information
Pathway
510K
Number
K244046 ↗
Decision Date
March 27, 2025
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Edwards eSheath Optima Introducer Set was cleared through the FDA 510(k) pathway on March 27, 2025. Manufactured by Edwards Lifesciences, this device is classified as a Class II medical device under product code DYB.
What It Is
The Edwards eSheath Optima Introducer Set is a specialized introducer sheath designed to facilitate the insertion of catheters and other interventional devices into the vascular system. It features a flexible design to accommodate various device sizes and minimize trauma to the vessel. This device is particularly useful in complex cardiovascular procedures where precision and safety are paramount.
Clinical Applications
This introducer set is commonly used in interventional cardiology, particularly during transcatheter aortic valve replacement (TAVR) procedures. It is suitable for use in hospital settings, especially in catheterization labs, and is utilized by cardiologists and interventional radiologists. The device is designed to accommodate a wide range of patient anatomies, making it versatile for different patient populations.
Indications for Use
The FDA-cleared indications for this device include its use in facilitating the introduction of therapeutic devices into the vascular system. It is particularly indicated for patients undergoing procedures that require vascular access, such as those with aortic stenosis requiring TAVR.
Practical Considerations
The Edwards eSheath Optima Introducer Set is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with a range of interventional devices, and clinicians should ensure proper sizing and technique to minimize vascular trauma during insertion.
Frequently Asked Questions
What is the Edwards eSheath Optima Introducer Set used for?
It is used for introducing catheters and other devices into the vascular system during interventional procedures like TAVR.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device in catheterization labs.
What are the FDA-cleared indications?
The device is indicated for use in facilitating the introduction of therapeutic devices into the vascular system, especially during procedures like 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.