đź“‹ FDA Reference
Impella Xr Sheath Set
Summary: The Impella XR Sheath Set is a medical device used in interventional cardiology to facilitate the placement of the Impella heart pump. It is typically used by cardiologists in catheterization labs for patients requiring mechanical circulatory support.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K202330 ↗
Decision Date ?
December 7, 2020
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The Impella XR Sheath Set, manufactured by Abiomed, was cleared through the FDA 510(k) pathway on December 7, 2020. It is classified as a Class 2 device under product code DYB.
What It Is
The Impella XR Sheath Set is designed to aid in the insertion of the Impella heart pump, a percutaneous ventricular assist device. It consists of a sheath that provides a conduit for the Impella catheter to be advanced into the heart. The sheath is engineered to minimize vascular trauma and facilitate smooth delivery of the device, which is crucial for patients requiring temporary mechanical circulatory support.
FDA-Cleared Indications
- Facilitates the insertion and placement of compatible Impella heart pumps.
- Provides vascular access and a conduit for advancing the Impella catheter during procedures requiring temporary mechanical circulatory support.
Clinical Applications
- Placement of a compatible Impella heart pump during temporary ventricular support.
- Use during high-risk percutaneous coronary intervention when temporary mechanical circulatory support is indicated.
- Use in patients who require temporary support for severe cardiac dysfunction, when consistent with the labeling of the specific Impella system.
Practical Considerations
- The sheath must be used with the compatible Impella system and according to the current manufacturer instructions for use.
- Available size and configuration options should be matched to the Impella device, access vessel size and patient anatomy.
- Insertion is generally performed through arterial access under fluoroscopic and, when needed, ultrasound guidance.
- Potential access-site complications include bleeding, hematoma, arterial injury, limb ischemia and vascular occlusion.
- MRI compatibility, including conditions for any MRI examination, must be confirmed in the current device labeling; the sheath should not be assumed to be MRI safe.
Frequently Asked Questions
What is the Impella XR Sheath Set used for?
The Impella XR Sheath Set is used to facilitate the placement of the Impella heart pump, providing mechanical circulatory support during cardiac procedures.
What specialties typically use this device?
Interventional cardiologists typically use this device in catheterization labs during procedures requiring mechanical circulatory support.
What are the FDA-cleared indications?
The device is indicated for use in facilitating the placement of the Impella heart pump in patients requiring temporary mechanical circulatory support.
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.