Abiomed announced that the Food and Drug Administration (FDA) has approved the Impella Right Percutaneous (RP) System under a Humanitarian Device Exemption (HDE). This is the first percutaneous single access heart pump designed for right heart support to be approved by the FDA.
The Impella RP Systems indicated to provide circulatory assistance for up to 14 days in patients who develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery. Through a small catheter in the leg, the device provides up to 4L/min of hemodynamic support without surgical insertion.
As part of the HDE approval, two post-approval studies are required for the RECOVER RIGHT trial — one study of 30 adult patients and another study of max 15 pediatric patients (aged <18 years). These single-arm multi-center studies will follow the respective patients 30 and 180 days post-device explant.
Abiomed is planning a controlled launch of Impella RP after each site has completed the in-house training.
For more information visit Abiomed.com.