BOSTON (Thomson Financial) - Abiomed Inc. Monday said it received
conditional approval from the Food and Drug Administration to begin its Impella
2.5 circulatory support system study in the U.S. under an investigational device
exemption.
The company's Impella 2.5 is used for patients undergoing a percutaneous
coronary intervention procedure because of acute myocardial infarction, commonly
referred to as heart attack.
Abiomed said the approval is conditional upon its submission of additional
information to the FDA over the next 45 days.
Shares of the Danvers, Mass.-based company rose 2.6% to $13.31.
Casey Logan
cl/jw
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