Abiomed shares sink as FDA votes to keep Impella pump at highest risk level

Fri, 12/07/2012 - 12:40pm
Mass Device

The FDA's Circulatory System Devices Panel votes to keep Abiomed's Impella heart pump at a Class III risk level, meaning the devices will continue to pass through the premarket review process.

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Abiomed (NSDQ:ABMD) shares slid 7% on Wall Street after the Danvers, Mass.-based cardiac devices maker lost a bid to have its star Impella heart pumps shifted to a lower FDA review risk category.

The FDA's Circulatory System Devices Panel yesterday voted to keep non-roller type cardiopulmonary blood pumps at Class III status, including the Impella, which has U.S. market clearance under the FDA's less stringent 510(k) pathway.


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