According to Michael Minogue, CEO of Abiomed, the latest challenges at the company have left him unfazed. In addition to a probe by the United States Department of Justice, the U.S. Food and Drug Administration has required the company to apply for premarket approval for its Impella heart pump.

Abiomed is a healthcare products company based in Danvers, Massachusetts. Following the public announcement of the DOJ probe, share prices at the company dropped 30 percent in one day. Less than one month later, the company received a notice from the FDA informing it of changes in its PMA protocol. With the new requirement, the company’s Impella heart pump will have to undergo expensive and time-consuming clinical trials prior to approval. However, Minogue has dismissed concerns about the company’s future.

During a conference call, Minogue said, "I think that there definitely was noise. For the most part, our average user and physician is not tied into that noise. Certainly some folks may hear about it and track more of the information.” He continued, "The most important factor to customers, again, is just improving patient outcomes, so I think in their grand scheme they are really, again, focused on using the technology, because they believe it's the right thing for their patients."

According to the DOJ, the probe has resulted in at least three lawsuits against Abiomed. Two of these are class action lawsuits and one is a shareholder derivative suit. All concern the company’s marketing practices for its Impella 2.5 heart pumps.

References

www.massdevice.com/news/abiomed-ceo-shrugs-impact-doj-probe-fda-call?pag...