Abiomed got the green light from the FDA yesterday to market its Impella 2.5 Cardiac Assist Device. This 510(k) allows Abiomed to begin selling the device to an estimated 1,700 heart hospitals in the U.S. The company will target about 300 hospitals at launch.
Impella sales alone could generate revenues on par with the $58.4 million Abiomed earned in 2007, this according to Greg Simpson, an analyst at Stifel Nicolaus. Simpson estimates that the device will bring $50 million in sales by 2009.
The Impella 2.5 is a minimally invasive, ventricular assist device, inserted percutaneously in the cardiac cath lab through the femoral artery into the left ventricle. The pump can deliver up to 2.5 liters of blood per minute from the left ventricle into the ascending aorta, providing the heart with support in critical situations (intra-aortic balloon pumps, the current standard of care, only pump blood at a rate of 2.0 liters per minute). The device was approved for up to six hours of use.
Impella allows the heart to rest and recover by actively unloading the left ventricle, reducing myocardial workload and oxygen consumption and increasing cardiac output so that organs (and the heart itself) receive adequate blood and oxygen.
Impella is now approved in more than 40 countries, including in Europe for up to seven days of support. The device has been used to treat over 1,500 patients outside the U.S. Results have validated Impella’s ease of use, low stroke rates and improved patient outcome.
Michael Minogue, President and CEO of Abiomed, commented, “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.”