The US Food and Drug Administration (FDA) has granted pre-market approval (PMA) for Abiomed’s Impella RP Flex with SmartAssist for the treatment of acute right heart failure.
The Impella RP Flex with SmartAssist System has been approved to provide temporary right ventricular support for up to 14 days.
It is indicated for the treatment of patients with a body surface area of more than or equal to 1.5m² and acute right heart failure or decompensation after the implantation of a left ventricular assist device, myocardial infarction, heart transplantation or open-heart surgery.
