Abiomed's dilemma is of its own making, Jefferies & Co. analyst Raj Denhoy tells MassDevice.com.
UPDATED Dec. 14, 2012, at 10:30 a.m.
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%.