FDA OKs 'world's smallest heart pump'
biz.yahoo.com
DANVERS, Mass.--(BUSINESS WIRE)--June 2, 2008--Abiomed, Inc. (NASDAQ: ABMD) today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Impella 2.5 Cardiac Assist Device. This 510(k) clearance allows Abiomed to begin selling the device to the estimated 14,000 interventional cardiologists at approximately 1,700 heart hospitals in the United States.
"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," said Michael R. Minogue, Chairman, Chief Executive Officer and President of Abiomed. "The device seamlessly provides immediate, minimally invasive circulatory support for critical patients."
The Impella 2.5 is inserted percutaneously in the catheterization laboratory via the femoral artery into the left ventricle. Up to 2.5 liters of blood per minute are delivered by the pump from the left ventricle into the ascending aorta, providing the heart with active support in critical situations.
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 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.
The Impella 2.5 is now approved in more than 40 countries, including in Europe for up to seven days of support under the CE Mark. The Impella platform has been used to treat over 1,500 patients outside the U.S. and has been the subject of more than 40 peer reviewed publications. |
