World's Smallest Heart Pump Receives 510(k) Clearance from FDAThe U.S. Food and Drug Administration just cleared the Impella 2.5 Cardiac Assist Device for immediate use. Designed for cardiac arrest and heart attack patients, it pumps up to 2.5 liters of blood per minute, and supports the heart in situations when it cannot function on its own. Each year over a million people in the U.S. have a heart attack, according to the National Institutes of Health. Of that statistic, half of them die and many are left with permanent heart damage.
The Impella 2.5 is inserted percutaneously in the catheterization laboratory through the femoral artery into the left ventricle. It is the only device designed to actively unload blood from the ventricle and is approved for short term use for up to six hours.
Today's clearance allows Abiomed to begin selling the device for use to the estimated 14,000 interventional cardiologists at approximately 1,700 heart hospitals in the United States.
For more information, go to www.abiomed.com.
Produced for Abiomed, Inc.
