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VIDEO from Medialink and Abiomed: World's Smallest Heart Pump Receives 510(K) Clearance from FDA

Wednesday, June 4, 2008 General News
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NEW YORK, June 3 The U.S. Food and Drug Administration(FDA) just cleared the Impella 2.5 Cardiac Assist Device for immediate use.Designed for cardiac arrest and heart attack patients, it pumps up to 2.5liters of blood per minute, and supports the heart in situations when itcannot function on its own. Each year over a million people in the U.S. havea heart attack, according to the National Institutes of Health. Of thatstatistic, half of them die and many are left with permanent heart damage.
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As the world's smallest Ventricular Assist Device (VAD), this technologyprovides patients with immediate, sustained coronary perfusion when theirheart is unable to do so. The Impella 2.5 is inserted percutaneously in thecatheterization laboratory (cath lab) through the femoral artery into the leftventricle. It is the only device designed to actively unload blood from theventricle and is approved for short term use for up to six hours.
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The clearance allows Abiomed to begin selling the device for use to theestimated 14,000 interventional cardiologists at approximately 1,700 hearthospitals in the United States.

For more information, go to http://www.abiomed.com.

Registered journalists can access video, audio, text, graphics and photosfor free and unrestricted use at http://www.mediaseed.tv.

06NY08-0084(See video from Abiomed, Inc. at:http://media.medialink.com/WebNR.aspx?story=35182)

SOURCE Medialink and Abiomed
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