Impella RP®
Overview
The Impella RP heart pump is the world’s first and only percutaneous device for right heart support.
This technology pumps blood from the inferior vena cava to the pulmonary artery. The pump is inserted with venous access and advanced over a wire into the pulmonary artery using standard catheterization techniques.
- Provides circulatory assistance for up to 14 days in certain patients with a body surface area ≥ 1.5 m2
- Delivers flow > 4.0 L/min of blood
- Enables biventricular support when the left side is already supported with a left-sided Impella® device
Indication and Safety Information EU
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.
• Arteriosclerosis, in particular calcification or other disorders of the pulmonary artery wall
• Mechanical valves, severe valvular stenosis or valvular regurgitation of the tricuspid valve or pulmonary valve
• Mural thrombus of the right atrium or vena cava
• Anatomic conditions precluding insertion of the pump
• Other illnesses or therapy requirements precluding use of the pump
• Presence of a vena caval filter or caval interruption device, unless there is clear access from the femoral vein to the right atrium that is large enough to accommodate a 22 Fr catheter
There are risks of complications with every procedure using a blood pump. These include among others:
• Hemolysis
• Bleeding
• Immune reaction
• Embolism, thrombosis
• Vascular injury through to angionecrotomy
• Infection and septicemia
• Endocardiac injuries due to attachment of the pump to the inferior vena cava
• Pump failure, loss of pump components following a defect
• Patient dependency on the pump after use for support
In addition to the risks above, there are other WARNINGS and PRECAUTIONS associated with Impella RP. For more information please see the Instructions for Use Manual.
IMP-3058