Abiomed Inc.’s Impella 2.5 cardiac pump and other pre-amendment, nonroller-type cardiopulmonary bypass blood pumps for temporary ventricular support should remain class III, with a PMA study requirement to further assess safety and effectiveness, FDA’s Circulatory System Devices panel concluded Dec. 6.
As pre-amendment class III devices, nonroller blood pumps intended for ventricular support for up to six hours are currently cleared...