FDA grants Abiomed breakthrough device designation for expandable heart pump

Ariana Portalatin - Print  |

Danvers, Mass.-based medical device company Abiomed received the FDA's breakthrough device designation for its Impella ECP heart pump.

The designation means the FDA will prioritize the device's regulatory review processes, according to an Aug. 18 news release.

According to Abiomed, the Impella ECP pump is the world's smallest heart pump that expands inside the body to support the heart's blood flow.

Abiomed was granted the designation after reporting positive clinical data from a study of 21 patients treated with the heart pump.

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