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.

The device is implanted in patients through their internal jugular (IJ) vein to enable patient mobility.

It features a dual-sensor technology that has been designed for optimising patient management.

The Impella RP Flex also includes the smallest percutaneous right heart mechanical circulatory support (MCS) technologies in the world.

These technologies were designed to help patients achieve native heart recovery and do not require extracorporeal blood circulation.

Abiomed stated that the Impella RP Flex has single venous access through the IJ vein with an 11 French (Fr) indwelling catheter.

The device includes a flexible cannula advanced over an extra-support guidewire, which enables ease of insertion and pump delivery.

Additionally, Impella RP Flex features SmartAssist dual-sensor technology combined with Impella Connect to deliver advanced metrics for weaning and pump management.

It has a heparin-free purge to simplify patient anticoagulant management.

Abiomed intends to launch Impella RP Flex with SmartAssist in the US in a controlled manner this quarter.

Recently, the company’s Impella Low Profile Sheath received 510(k) clearance from the US FDA.