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European Approval Granted for Temporary Heart Pump

Human heart and arteries (Yale School of Medicine/Wikimedia Commons)

(Yale School of Medicine/Wikimedia Commons)

Abiomed Inc. in Danvers, Massachusetts, a developer of medical devices for circulatory support, says its Impella cVAD heart pump has received a CE mark indicating approval to market the device in EU member countries. The marking, an  acronym for the French Conformité Européenne, certifies that a product has met EU health, safety, and environmental requirements.

The company says the Impella cVAD is a minimally invasive, catheter-based pump that is inserted under the skin, without the need for surgical intervention, and designed to provide temporary circulatory support with a peak flow of about 4 liters of blood per minute. The devise is intended for use in cardiology and cardiac surgery for up to 5 days.

Abiomed says the CE mark permits use of the Impella cVAD for patients with reduced left ventricular function, such as post-cardiotomy, low output syndrome, cardiogenic shock after acute myocardial infarction, or for myocardial protection after acute myocardial infarction. The Impella cVAD may also be used as a cardiovascular support system during coronary bypass surgery on the beating heart.

The company expects the Impella cVAD to be fully available in Europe by the summer of 2012. The device is not yet approved for sale or use in the U.S.

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