Impella®RPwith the Automated Impella®ControllerCirculatory Support SystemINSTRUCTIONS FOR USE& CLINICAL REFERENCE MANUAL(United States only)Humanitarian Device. Authorized by Federal law (USA) to provide circulatoryassistance for up to 14 days in pediatric or adult patients with a body surfacearea ≥1.5 m2 who develop acute right heart failure or decompensation followingleft ventricular assist device implantation, myocardial infarction, heart transplant,or open-heart surgery. The effectiveness of this device for this use has not beendemonstrated.
