Device Dossier
Impella CP with SmartAssist REF 0048-0008 - Intracardiac circulatory assist axial-pump catheter
Device Dossier for Impella CP with SmartAssist REF 0048-0008 - Intracardiac circulatory assist axial-pump catheter (Intracardiac circulatory assist…
- GMDN category: Intracardiac circulatory assist axial-pump catheter
Intended purpose
ImpellaCP® with SmartAssist pump is a intracardiac pump for supporting the left ventricle; it is intended for clinical use in cardiology and in cardiac surgery for up to 5 days for supporting the native heart in patients with reduced left ventricular function`
Functional description
The ImpellaCP® pump supports the native heart by directly unloading the left ventricle. It is a circulatory support system for recovery and prophylactic or elective support during high risk percutaneous coronary intervention(PCI), post PCI, and for patients with reduced left ventricular function; it may also be used during coronary bypass surgery on the beating heart in patients with high risk of postoperative low output syndrome