Shares of Abiomed lost 6% yesterday after a conference call with analysts on the medical device company's plans to comply with an FDA panel's decision that its Impella heart pump should undergo the watchdog agency's pre-market approval review.
Shares of Abiomed (NSDQ:ABMD) lost nearly 7% yesterday after a conference call with analysts discussing an FDA panel's decision to require further review of clinical data for its flagship Impella heart pump.
Last week the federal watchdog agency's Circulatory Devices Advisory panel ruled that some cardiovascular pump makers, including Danvers, Mass.-based Abiomed, must submit already-approved medical devices for review under the more-stringent pre-market approval pathway. The various Impella devices can stay on the U.S. market in the meantime.
Although the panel acknowledged that non-roller-type cardiopulmonary bypass blood pumps are life-supporting, it recommended against shifting them to a lower-risk category for temporary ventricular support. The decision sent ABMD shares spiraling downward Dec. 7, dropping as low as $12 per share in morning trading before closing at $12.49 apiece, down 3.0%.