Abiomed Impella 2.5 Gets FDA Approval For Urgent High Risk PCI Procedures

(RTTNews) - Abiomed Inc. (ABMD), a provider of breakthrough heart support technologies, announced that it has received U.S. Food and Drug Administration or FDA Pre-Market Approval or PMA for the Impella 2.5 heart pump during elective and urgent high risk percutaneous coronary intervention or PCI procedures.

With this approval, the Impella 2.5 is a temporary (= 6 hours) ventricular support device indicated for use during high risk 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 that may occur during planned temporary coronary occlusions and may reduce peri- and post-procedural adverse events.

The product labeling allows for the clinical decision to leave Impella 2.5 in place beyond the intended duration of =6 hours due to unforeseen circumstances.