Impella 5.5 with SmartAssist - Intracardiac circulatory assist axial-pump catheter

Risk Class

Class III

Product Type

Single Device Product

ARTG Category

General

Start Date

April 11, 2022

Effective Date

November 14, 2023

Name

Abiomed Australia Pty Ltd

Name

Abiomed Inc

Country

United States of America

Address

22 Cherry Hill Drive, DANVERS, MASSACHUSETTS, USA, 01923

The Impella 5.5® with SmartAssist® heart pump is an intracardiac pump for supporting the left ventricle. It is intended for clinical use in cardiology and in cardiac surgery for up to 29 days for the following indications, as well as others: • The Impella 5.5 with SmartAssist heart pump is a cardiovascular support system for patients with acutely reduced left ventricular function, e.g. low output syndrome, cardiogenic shock after acute myocardial infarction. • The Impella 5.5 with SmartAssist heart pump is also a temporary support system for patients in need of circulatory support due to chronically reduced left ventricular function, e.g. for bridging patients with chronic heart failure to implantable assist device, heart transplantation, or myocardial recovery / stabilization. • The Impella 5.5 with SmartAssist heart pump may also be used as a cardiovascular support system during cardiological interventions or heart surgery (e.g. coronary bypass surgery), particularly in patients with limited preoperative ejection fraction with a high risk of postoperative low output syndrome, or in cases of difficulties to wean from heart-lung machine support.