📋 FDA Reference
Edwards Esheath Optima Introducer Set
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 ?
510(k)
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.
FDA-Cleared Indications
- Facilitates the introduction of therapeutic devices into the vascular system.
- Provides vascular access for procedures requiring insertion of catheters or other interventional devices.
- Intended for use by trained healthcare professionals in appropriate clinical settings.
Clinical Applications
- Providing vascular access during transcatheter aortic valve replacement (TAVR).
- Introducing therapeutic cardiovascular devices through the vascular system.
- Supporting catheter-based procedures performed in a hospital catheterization or interventional procedure laboratory.
Practical Considerations
- The sheath must be selected in a size compatible with the therapeutic device and the patient's access vessel.
- Use fluoroscopic or other appropriate imaging guidance and careful access-site technique to reduce the risk of bleeding, dissection, perforation, or other vascular injury.
- The device is intended for single-use applications; do not reuse or resterilize unless the labeling specifically permits it.
- MRI safety and conditional-use information should be confirmed in the current Edwards product labeling before an MRI examination.
- Contraindications, warnings, access-site requirements, and compatible device sizes should be checked in the current instructions for use before use.
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.