BOSTON (Thomson Financial) - Abiomed Inc. Friday said it "remains confident"
that its Impella 2.5 circulatory support device is on the substantially
equivalent path based on informal feedback from the Food and Drug
Administration.
The company is currently in a review with the FDA on bench testing results
of the Impella 2.5, the remaining area of concern.
Abiomed said the review of the bench testing results will not be completed
by the FDA before March 31, the company's original forecasts.
Abiomed now estimates the review by the FDA will be completed some time
during the June quarter.
Shares of the Danvers, Mass.-based company fell 9.5% to $12.92.
Casey Logan
cl/pc
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