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

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Abiomed Australia Pty Ltd

Class:

Class III

Manufactured by:

Abiomed Inc 22 Cherry Hill Drive, DANVERS, MASSACHUSETTS, USA, 01923 United States Of America

Therapeutic area:

56732 - Intracardiac circulatory assist axial-pump catheter

Therapeutic indications:

The Impella 5.5 with SmartAssist is an intravascular microaxial blood pump that supports a patient's circulatory system and is inserted via the axillary artery cut-down through the artery and into the left ventricle(LV) or surgically as direct aortic insertion. It delivers blood from the inlet area, which sits inside the LV, through the cannula, to the outlet opening in the ascending aorta. The pump reduces the workload of the heart as it continuously draws blood from the LV. 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.

Authorization status:

A

Authorization date:

2022-04-11