Abiomed plunges 30% on federal investigation into Impella marketing

November 1, 2012 by MassDevice staff

Wall Street investors fled from heart pump maker Abiomed (NSDQ:ABMD) today, with shares down more 30% in mid-day trading following the company's latest earnings report and news of a federal investigation.

Abiomed unveiled today that it received notice from the U.S. Attorney's Office for the District of Columbia that the agency is conducting an investigation into marketing and labeling for the Impella 2.5 implantable heart pump.

Yesterday the Danvers, Mass.-based medical device maker received a subpoena from the Health Insurance Portability and Accountability Act, according to regulatory documents.

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"The subpoena seeks documents related to the Impella 2.5 and we understand the investigation focuses primarily on marketing and labeling issues," according to an Abiomed SEC filing. "We are in the process of responding to the subpoena and intend to cooperate fully."

Abiomed chairman, president & CEO Michael Minogue told investors during a conference call today that the company plans to be completely transparent about the investigation, but couldn't offer any additional details.

Impella 2.5 won FDA 510(k) clearance in June 2008, Minogue said, with indication for "partial circulatory support, using an extracorporeal bypass control unit for periods of up to 6 hours," with additional indication for use during procedures not requiring cardiopulmonary bypass.

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