INDICATIONS (UNITED STATES)
The Impella RP System is indicated for providing circulatory assistance for up to 14 days in pediatric
or adult patients with a body surface area
≥ 1.5 m
2
who develop acute right heart failure or
decompensation following left ventricular assist device implantation, myocardial infarction, heart
transplant, or open-heart surgery.
CONTRAINDICATIONS (UNITED STATES)
• Disorders of the pulmonary artery wall that would preclude placement or correct positioning
of the Impella RP device
• 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 cava 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
Impella
®
RP with the Automated Impella
®
Controller
1.1
