Impella 2.5 heart pump has FDA approval for High Risk PCI procedures- AbioMed Inc.

Abiomed, Inc. announced that it has received FDA Pre-Market Approval (PMA) for the Impella 2.5 heart pump during elective and urgent high risk percutaneous coronary intervention (HRPCI) procedures. Impella 2.5, the world's smallest heart pump, is the first hemodynamic support device to receive a PMA indication for use during high risk PCI procedures, demonstrating its safety and effectiveness for this complex patient population. With this approval, the Impella 2.5 is a temporary (less than 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.

Comment:The Impella 2.5 System is a heart pump intended for temporary use by patients with severe symptomatic CAD and diminished (but stable) heart function who are undergoing HRPCI but are not candidates for surgical coronary bypass treatment. In patients with diminished heart function, the heart pumps less blood than normal every time it beats, which is sometimes associated with CAD. Throughout an HRPCI procedure, the Impella 2.5 System helps maintain stable heart function by drawing blood from the left lower chamber of the heart (left ventricle) and pumping it into the aorta, the main blood vessel leading away from the heart that supplies oxygen-rich blood to the body. Data supporting the approval of the Impella 2.5 System included clinical data from the manufacturer�s PROTECT II clinical study with supporting information obtained from the USpella Registry, a multi-center, observational registry. The overall data provided evidence that, for patients with severe CAD and diminished heart function, the temporary circulatory support provided by the Impella 2.5 System during a HRPCI procedure may allow a longer and more thorough procedure by preventing episodes of hemodynamic instability (e.g., poor circulation, low blood pressure) due to temporary abnormalities in heart function.