FDA Designates Abiomed’s Impella ECP Heart Pump a Breakthrough Device

Danvers, Mass.-based Abiomed’s expandable cardiac pump, Impella ECP, has received a breakthrough device designation from the FDA.

Impella ECP is a small heart pump that is compatible with small-bore access and closure techniques. It is 3 millimeters in diameter upon insertion but expands inside the heart to support the pumping function, providing flow of more than 3.5 liters per minute.

The agency granted the breakthrough status based in part on positive clinical data from the first 21 patients treated with the percutaneous heart pump as part of an early feasibility study.