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Abiomed’s Impella Cardiac Pump Needs PMA Study, FDA Panel Says

Better data is needed in the form of a PMA study to assess the safety and effectiveness of Abiomed’s flagship Impella 2.5 blood pump, advisory panel recommends.

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 and marketed through the 510(k) pathway, but the technology “is...

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