FDA Approves Abiomed’s Heart Pump

July 1, 2021

Danvers, Mass.-based Abiomed’s right-heart pump, the Impella RP with SmartAssist, has received premarket approval from the FDA.

In June 2020, the FDA issued an Emergency Use Authorization for the Impella RP as a treatment for patients suffering from COVID-19-related right-heart failure or decompensation, including pulmonary embolism.

The pump, which is now cleared to treat acute right-heart failure for up to 14 days, includes sensors that allow remote monitoring from internet-connected devices.

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