Abiomed has received 510(k) clearance from the FDA for its Impella 2.5 cardiac assist device.
The Impella 2.5 is inserted percutaneously in the cath lab via the femoral artery into the left ventricle, the company said. 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, Abiomed said. The intra-aortic balloon pump (IABP) also has 510(k) clearance and the company is currently conducting two U.S. pivotal studies comparing the Impella 2.5 to the IABP.
The 510(k) clearance allows Abiomed to begin selling the device to the estimated 14,000 interventional cardiologists at approximately 1,700 U.S. heart hospitals, according to the Danvers, Mass.-based company.