Impella Heart Pump Approved for Acute Right Heart Failure
Abiomed’s Impella RP Flex with SmartAssist heart pump has received FDA’s premarket approval to provide temporary right ventricular support for up to 14 days.
The device is used for acute right heart failure following left ventricular assist device implantation, myocardial infarction, heart transplant or open-heart surgery.
The device features the world’s smallest percutaneous right heart mechanical circulatory support technologies, the company said. The pump, which does not require blood to circulate in a machine outside the body, is the only mechanical circulatory support technology approved for the treatment of right heart failure.