FDA awards Breakthrough Device Designation to Impella ECP
On August 18, 2021, Abiomed received breakthrough device designation from the United States Food and Drug Administration (FDA) for its Impella ECP expandable percutaneous heart pump, the world’s smallest heart pump and the first to be compatible with small-bore access and closure techniques.
This designation was based on positive clinical data from the first 21 Impella ECP patients treated as part of an FDA-regulated early feasibility study and will give priority during the Impella ECP’s regulatory review processes comprising of design iterations, clinical study protocols, and pre-market...
