Abiomed ($ABMD) has finally cleared the FDA's warning letter over how it marketed the Impella 2.5 heart pump, and now the company can focus on improving sales and getting back in investors' good graces.
The Massachusetts devicemaker says the feds have issued a close-out letter, meaning the FDA is satisfied with Abiomed's corrective actions since the initial 2011 violation. The agency took issue with how Abiomed billed Impella to customers, saying the company pitched beyond its intended use and FDA-approved indications.
However, while Abiomed now has the FDA off its back, the Impella fallout goes beyond regulatory scrutiny. In November, two investors filed a class-action lawsuit, claiming Abiomed willfully misled the public on the way to the warning letter. The company says the suit is without merit and plans to "vigorously defend itself."
But, despite the lawsuit, other investors seem elated with Abiomed's progress. The company's shares spiked about 4% after the all-clear announcement, and Abiomed is crawling back on the Street after it tanked 31% in November.
Last quarter, Abiomed posted $38.3 million in revenue, a 19% increase over the previous year, thanks in large part to 21% growth in worldwide Impella sales. Looking forward, Abiomed is working to expand the pump's international reach and nail down FDA approval for a percutaneous application of Impella CP, hoping to qualify for the agency's speedier humanitarian device exemption.
- read Abiomed's announcement