FDA OKs Abiomed’s Impella 5.5 with SmartAssist

Abiomed’s (NASDAQ:ABMD) newest heart pump, the Impella 5.5 with SmartAssist, has received FDA pre-market approval (PMA) for safety and efficacy in the therapy of cardiogenic shock for up to 14 days.

The Impella 5.5 with SmartAssist will be introduced in U.S. through a controlled rollout at hospitals with established heart recovery protocols.

https://seekingalpha.com/news/3501685-fda-oks-abiomeds-impella-5_5-smartassist