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%.

Sign up to get our free newsletters delivered straight to your inbox

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.


Built on an AdaptiveTheme using Drupal by Michael Knapp  mknapp