|Expedited Review Granted?|| No|
||Labeling, Approval Order, Summary of Safety and Effectiveness|
|Approval Order Statement |
Approval for the impella. This device is indicated for: the impella 2. 5 system is a temporary (<= 6 hours) ventricular support device indicated for use during high risk percutaneous coronary interventions (pci) performed in elective or urgent, hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction, when a heart team, including a cardiac surgeon, has determined high risk pci is the appropriate therapeutic option. Use of the impella 2. 5 in these patients may prevent hemodynamic instability which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri- and post-procedural adverse events.
|Post-Approval Study||Show Report Schedule and Study Progress|