CardioExchange Archive

CardioExchange, an NEJM practice community for medical professionals dedicated to improving cardiac patient care, was active from 2009 to 2015. CardioExchange fostered discussion between clinicians from across the globe.

November 1st, 2012

DOJ Investigating Abiomed for Improper Marketing of Impella Circulatory Support System

The U.S. Attorney’s Office is investigating Abiomed’s marketing and labeling of the Impella 2.5 circulatory support device, the company announced on Thursday.

Abiomed also said that it believed that the FDA would begin a review to possibly reclassify its Impella devices as Class III devices, which would require FDA clearance using the more stringent premarket approval (PMA) process instead of the current, less demanding 510(k) premarket notification process. Whether because of the DOJ investigation or the FDA announcement, the stock price of Abiomed dropped 25% with the news.

This is not the first time Abiomed has run into trouble with the FDA. In June 2011, Abiomed received a warning letter from the FDA about improper marketing of Impella for unapproved indications.

As previously reported here, in December 2010, the company issued a press release announcing — and spinning — the results of the PROTECT II trial comparing Impella to the intra-aortic balloon (IAB) in high-risk PCI patients. Although the trial was stopped early for futility, the press release downplayed the negative findings and instead emphasized positive trends and encouraging subgroup analyses. Last month, when the trial was finally published in Circulation, the company issued a much more restrained press release, perhaps a reflection of the company’s efforts to avoid further problems with the FDA.

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