A U.S. Justice Dept. investigation and the FDA’s decision to require pre-market approval for Abiomed’s Impella heart pump leave CEO Michael Minogue unfazed.
Cardiologists aren’t paying much attention to the noise around Abiomed (NSDQ:ABMD) and its flagship medical device, the Impella heart pump, at least according to chairman, president & CEO Michael Minogue.
That noise centered around a pair of events during the 4th quarter: news of a U.S. Justice Dept. probe into its marketing of the Impella pump and an FDA decision to require the device to undergo a more rigorous approval process.
The Danvers, Mass.-based medical device company revealed the DoJ probe last year, sending share prices down more than 30% in a day. A month later a federal watchdog agency panel voted to require that the Impella undergo the FDA’s pre-market approval protocol, which ordinarily requires extensive clinical trials before approval is granted.