News
Abiomed receives FDA approval for Impella
Massachusettes, USA
Jun 2, 2008
Abiomed, Inc. has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Impella 2.5 Cardiac Assist Device.
The Impella 2.5 is used in the catheterisation laboratory through the femoral artery into the left ventricle. Up to 2.5 litres of blood per minute is delivered by the pump, providing the heart with active support in critical situations.
Commenting on the occasion, Chief Executive Officer and President of Abiomed, Michael R. Minogue said, “FDA clearance of the Abiomed Impella 2.5 represents the next step in enabling heart recovery for patients in the U.S. and will likely change the standard of care in the catheterization lab. The device seamlessly provides immediate, minimally invasive circulatory support for critical patients.”
© 2010 Ochre Media. All rights reserved.