Posted by Michael Wonder on 18 Aug 2021
FDA grants breakthrough device designation to Impella ECP, the world’s smallest heart pump
18 August 2021 - The United States FDA has granted breakthrough device designation to Abiomed’s Impella ECP expandable percutaneous heart pump.
The designation means the FDA will prioritise Impella ECP’s regulatory review processes including design iterations, clinical study protocols and pre-market approval application.
Impella ECP is the smallest heart pump in the world and the first to be compatible with small bore access and closure techniques. It measures 9 French (3 mL) in diameter upon insertion and removal from the body. While in the heart, it expands to support the heart’s pumping function, providing flow greater than 3.5 L/min.
