Real-world Experience Of Adverse Events And Modes Of Failure Related To The New Impella 5.5 - A Retrospective Analysis From Manufacturer And User Facility Device Experience Database

Impella 5.5 with Smart Assist is the newest heart pump that has received U.S. Food and Drug Administration (FDA) pre-market approval in 2019 for safety and efficacy in the therapy of cardiogenic shock for up to 14 days at limited centers in the United States. Impella consists of several different models that vary in caliber, insertion technique, and maximum hemodynamic support capabilities. Impella 5.5 is minimally invasive, implanted via the axillary artery or the anterior aorta eliminating the need for a sternotomy or coring of the left ventricle unlike older versions.
Source: Journal of Cardiac Failure - Category: Cardiology Authors: Tags: 027 Source Type: research