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impella xr sheath set
Abiomed
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
510K
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.
Clinical Applications
This device is commonly used in interventional cardiology, particularly in settings such as catheterization labs. It is utilized during procedures where the Impella heart pump is indicated, often in patients with severe heart failure or those undergoing high-risk percutaneous coronary interventions (PCI). The device is crucial in providing temporary support to patients with compromised cardiac function, ensuring hemodynamic stability during complex procedures.
Indications for Use
The FDA indications for the Impella XR Sheath Set include its use in facilitating the placement of the Impella heart pump in patients needing mechanical circulatory support. It is particularly indicated for patients with severe cardiac conditions requiring temporary ventricular support.
Practical Considerations
The Impella XR Sheath Set is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with the Impella heart pump system and requires careful insertion technique to minimize vascular complications. Clinicians should be trained in its use to ensure optimal outcomes.
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.