October 1, 2008 - Abiomed Inc. recently completed shipment of its Impella 2.5 Cardiac Assist Device to its 100th U.S. hospital following its June 2008 FDA clearance for partial circulatory support for periods up to six hours.
The intra-aortic balloon pump (IABP) also has 510(k) clearance and approximately 124,000 are used each year in the U.S. Abiomed is currently conducting two U.S. pivotal studies comparing the Impella 2.5 to the IABP (Protect II for high-risk percutaneous coronary intervention, or PCI; and Recover II for acute myocardial infarction, AMI). There are an estimated 60,000 annual high-risk PCI patients and 100,000 AMI anterior infarct patients annually in the U.S.
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 now approved in more than 40 countries, including in Europe under the CE Mark. The Impella platform has been used to treat more than 1,500 patients outside the U.S. and has been the subject of more than 50 peer-reviewed publications, the company said.
For more information: www.abiomed.com