DOJ clears Abiomed for marketing its Impella 2.5 device

The U.S. Department of Justice (DOJ) closed its investigation into Abiomed’s marketing of the Impella 2.5 device without taking any action against the company, according to an Abiomed news release on June 29.

On Nov. 1, 2012, Abiomed revealed the DOJ was investigating its marketing and labeling for the Impella 2.5, a ventricular assist device used during high-risk PCI. The device received 510(k) clearance in 2008. Abiomed said it fully cooperated with the DOJ since the probe began.

When the FDA granted premarket approval (PMA) of the Impella 2.5 in March 2015, Abiomed said it was the first hemodynamic support device to receive a PMA indication for patients undergoing high-risk PCI. The device is intended to be used for six hours or less in patients with severe coronary artery disease and depressed left ventricular ejection fraction.

The approval in March was based on data from more than 15,000 patients who received the device. Abiomed also has an ongoing registry that is monitoring high-risk patients at 49 centers in the U.S.