Device Dossier
Impella RP Model 0046-3107 - Intracardiac circulatory assist axial-pump catheter
Device Dossier for Impella RP Model 0046-3107 - Intracardiac circulatory assist axial-pump catheter (Intracardiac circulatory assist axial-pump catheter,…
- GMDN category: Intracardiac circulatory assist axial-pump catheter
Intended purpose
The Impella RP® System (percutaneous pump for right ventricular support) is intended for clinical use in cardiology, in cardiac surgery, and intensive care unit for up to 14 days for the following indications, as well as others: Acute or transient reduction of the right ventricular function (eg, postcardiotomy low output syndrome) Cardiogenic shock as a consequence of a posterior myocardial infarction with right ventricular heart failure Right heart support during coronary beating heart bypass surgery, especially for patients with a reduced preoperative cardiac output or for patients having a high risk of developing a postoperative low output syndrome for other reasons Right ventricular heart failure after implantation of a left ventricular assist device Therapy unresponsive arrhythmias with a reduction of right ventricular output Heart failure and/or cardiogenic shock as a consequence of refractory ventricular arrhythmias, as well as a consequence of sustained supraventricular arrhythmias, causing haemodynamic compromise.
Functional description
The Impella RP heart pump is an intracardiac microaxial blood pump that supports a patient's pulmonary circulation. The Impella RP is inserted percutaneously through the femoral vein and into the pulmonary artery. The Impella RP delivers blood from inferior vena cava, through the cannula to the outlet opening in the pulmonary artery. The Impella RP pump reduces the workload of the right heart as it continuously pumps blood from the inferior vena cava into the pulmonary artery