Impella 5.5 with SmartAssist - Intracardiac circulatory assist axial-pump catheter - ARTG 386932
Access comprehensive regulatory information for Impella 5.5 with SmartAssist - Intracardiac circulatory assist axial-pump catheter in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 386932 and sponsored by Abiomed Australia Pty Ltd, manufactured by Abiomed Inc in United States of America. The device registration started on April 11, 2022.
This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.
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.