|An illustration of the Impella 2.5 pump in the heart--Screenshot courtesy of Abiomed|
Abiomed ($ABMD) escaped the wrath of the U.S. Department of Justice, as the DOJ decided to wrap up an investigation of the company's marketing of its Impella 2.5 heart pump device without taking additional action.
The legal drama dates back to 2012, when the U.S. Attorney's Office for the District of Columbia launched an investigation into the company's marketing and labeling for Impella, looking for documents that would bolster its case. But Abiomed has "cooperated fully" with the government inquiry, the company said in a statement, and is eager to lay its legal woes to rest.
"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 patients first," Abiomed CEO Michael Minogue said in a statement.
|Abiomed CEO Mike Minogue|
The news comes at a pivotal moment for Abiomed as it rides the tailwinds of recent success. In March, the FDA greenlighted the company's Impella 2.5 heart pump for a broader subset of patients, growing its market by 25,000 to 50,000 individuals in the U.S.
Now, with larger market potential for its products, Abiomed is setting its sights on expansion. Earlier this month, the company announced that it would add another 100 employees to its 600-employee base over the next two years and would lease another 85,000 square feet of space in a building next to its Danvers, MA-based headquarters, creating a 160,000-square-foot home base for manufacturing.
"What (the recent FDA approval) gives us is a license to go out and be the standard of care," Minogue said at the time. "We were planning for this success so that means we have to expand our manufacturing capacity, to build the quantities of product necessary."
And at least for now, Abiomed seems headed in the right direction. The company last month revealed fourth quarter numbers that beat analysts' expectations, including a 38% jump in global Impella revenue from the previous year. Abiomed raised its fiscal year 2016 guidance to $285 million to $295 million from an earlier range of $260 million to $270 million, charting ambitious plans for growth in the year ahead.
- read Abiomed's statement