The investigation began in October 2012 when Danvers, Mass.-based Abiomed said it was informed that the U.S. Attorney’s Office of the District of Columbia had initiated an investigation.
The DoJ informed the company it was seeking internal documents relating to Abiomed’s marketing and labeling of the Impella 2.5, the company said. Abiomed said it cooperated fully with the inquiry.
“We are pleased that the Department of Justice has chosen to close its investigation without pursuing any further action and that this matter is now behind us. We have always remained steadfast in our integrity and our commitment to putting our patients first,” CEO Michael Minogue said in a press release.
The Impella 2.5 is a percutaneous “micro heart pump” with integrated motor and sensors, which the company bills as the world’s smallest heart pump.
Abiomed won pre-market approval from the FDA for its flagship Impella 2.5 in March, after the FDA’s Circulatory Devices panel recommended in late 2012 that percutaneous cardiac assist devices be subject to the FDA’s most stringent PMA protocol. The pump had been allowed on the U.S. market via the FDA’s less-stringent 510(k) clearance protocol.