June 2, 2008 - Abiomed Inc. received 510(k) clearance from FDA for Impella 2.5 Device Cardiac Assist Device, allowing Abiomed to sell the device in the U.S.
The Impella 2.5 is cleared for use under the 510(k) for partial circulatory support for periods up to six hours. The intra-aortic balloon pump (IABP) also has 510(k) clearance and approximately 110,000 are used each year in the United States. Abiomed is currently conducting two U.S. pivotal studies comparing the Impella 2.5 to the IABP.
