In a press release on Monday, Massachusetts-based medical device manufacturer, Abiomed, notified the public that the U.S. Department of Justice has dropped its investigation of the company’s Impella 2.5 heart pump. In the press release, Company CEO, Michael Minogue said, “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.” The investigation was launched in October, 2012, with the Justice Department seeking documents related to the labeling and marketing of the device. Abiomed executives claimed that they were cooperating fully with the investigation. The device is used to stabilize the heart while patients undergo surgical procedures. Abiomed has marketed the Impella 2.5 to be the smallest heart pump in the world. The device can move 2.5 liters of blood per minute into the left ventricle during both necessary and elective surgeries.
News that the investigation was dropped comes after the Food and Drug Administration (FDA) granted Abiomed premarket approval (PMA) of the device in March under strict “Section 515” guidelines. Due to the critical nature and complexity of devices such as the Impella 2.5, the FDA recommended that percutaneous cardiac assist devices like the Impella 2.5 be rescheduled from the less stringent Section 510 rules that had previously governed the devices. The device had previously been approved under Section 510 rules in 2008, which require companies to show “at least as safe and effective, that is, substantially equivalent, to a legally marketed device.” The tougher Section 515 guidelines require the FDA to hold special device classification panel meetings in order to grant PMA. In order to gain the approval, Abiomed submitted its own clinical trial programs, PROTECT I and PROTECT II, as well as submitting evidence from 215 publications and citing 1,638 patients who used the Impella 2.5 during procedures. The Impella 2.5’s Section 515 approval is the first for a device of this kind. The company will also conduct a post-approval study, collecting data from high-risk patients.
Although details of the Justice Department’s investigation are largely unknown, The FDA sent Abiomed a warning letter in 2011 regarding the company’s marketing of Impella devices for unapproved indications. Although the Impella 2.5 is approved for 6 hours of use, the product labeling authorizes surgeons to keep the device in place for longer if unexpected complications arrive. In 2010, Abiomed released a statement comparing the Impella devices to the intra-aortic balloon (IAB) during its PROTECT II study. Although that portion of the study was scrapped due to futility, Abiomed downplayed the poor results and instead highlighted more ancillary portions of the study. In September of 2012, a month before the Justice Department began its investigation, the company released the results of the PROTECT II study, including a much more subdued press release. Although speculation, it would appear that either the change of tone stemmed from fear of governmental intervention, or the change in tone between 2010 and 2012 fueled the FDA and the Justice Department to investigate the matter further.
Cardiovascular Disease News – Charles Moore
Forbes – Larry Husten
MarketWatch – Globe Newswire
MassDevice – Fink Densford