Clinical Dossier Protected PCI with Impella®

On March 23, 2015, the Impella 2.5™ received PMA approval from the U.S. FDA* and on December 2, 2016 the Impella CP® received PMA approval from the U.S. FDA.


The clinical data demonstrating Impella’s safety and effectiveness includes > 1,600 patients from an FDA-randomized, controlled trial and a U.S. multi-center registry, as well as over 200 peer-reviewed publications in the high-risk PCI setting.

Impella 2.5 and Impella CP maintain patient hemodynamics during planned temporary coronary occlusions by maintaining mean arterial pressure (MAP), which may allow for a more thorough procedure and a more complete revascularization in a single session.