ABMD - Abiomed's Impella RP Flex gets FDA approval to treat right heart failure

The U.S. Food and Drug Administration (FDA) granted pre-market approval (PMA) to Abiomed's ( NASDAQ: ABMD )  Impella RP Flex with SmartAssist to treat acute right heart failure for up to 14 days.

According to the FDA, PMA is the most stringent type of device marketing application required by the U.S. drug regulator.

The company said on Monday that Impella RP Flex is implanted via the internal jugular (IJ) vein, which enables patient mobility, and has dual-sensor technology to optimize patient management.

The Impella RP platform includes the world's smallest percutaneous right heart mechanical circulatory support (MCS) technologies to help patients achieve native heart recovery. They do not require extracorporeal blood circulation and remain the only MCS technologies with FDA PMA uses to treat right heart failure, according to the company.

The complete FDA indication for Impella RP Flex with SmartAssist System is to provide temporary right ventricular support for up to 14 days in patients with a body surface area ?1.5 m2, who develop acute right heart failure or decompensation after left ventricular assist device implantation, myocardial infarction, heart transplant or open-heart surgery.

Abiomed noted that the device will be launched in the U.S. through a controlled rollout this quarter.

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