UPDATE: Did Abiomed fly too close to the sun?

December 14, 2012 by MassDevice staff

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.

Abiomed (NSDQ:ABMD) is impaled on the prongs of a 3-horned dilemma with its flagship Impella heart pump, and it's a problem of its own making, according to 1 Wall Street analyst.

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%.

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Jefferies & Co. analyst Raj Denhoy told MassDevice.com this morning that the FDA decision's implications are compounded by 2 other factors: A U.S. Justice Dept. probe into Abiomed's marketing of the Impella devices and a recent Centers for Medicare & Medicaid decision to consider a national coverage decision for them. But the root of the problem is the Protect II study, Denhoy told us, which Abiomed halted for futility reasons in December 2010.