FDA panel decision means Abiomed will need new PMA for Impella pump

Fri, 12/07/2012 - 3:42pm
Mass Device

An FDA advisory panel's decision to maintain Class III status on certain cardiovascular assistance devices means Abiomed and other device makers must re-apply for FDA approval.

Abiomed's Impella heart pump

An FDA panel decision issued this will require some cardiovascular pump makers to submit their already-approved medical devices for review under the FDA's more stringent premarket review pathway.

The federal watchdog agency's Circulatory Devices Advisory panel this week acknowledged that non-roller-type cardiopulmonary bypass blood pumps are life-supporting, but recommended against shifting them to a lower-risk category for temporary ventricular support. Panelists also suggested down-classification into Class II (special controls) for cardiopulmonary and circulatory bypass therapy.

The decision sent ABMD shares spiraling downward today, dropping as low as $12 per share in morning trading before recovering completely to reach last night's close of $12.88 by about 3:30 p.m.


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