AbioMed, a healthcare products manufacturer based in Danvers, Massachusetts, faces several serious issues regarding its Impella heart pump. According to a Wall Street analyst, many of the problems the company faces are caused by its own actions.
The previous week, the FDA Circulatory Devices Advisory panel made a ruling that required some cardiovascular pump manufacturers to re-apply for device approval under more stringent guidelines. In the meantime, Impella heart pumps can remain on the market.
According to the panel ruling, while non-roller-type cardiopulmonary bypass pumps play an important role in sife support, the devices may not be appropriate in a low-risk category that would allow for use as temporary ventricular support. This decision caused a significant drop in company share prices.
In addition to this issue, the company faces a probe from the U.S. Justice Department into its marketing practices for Impella heart pumps. In addition, the probe will look into the company’s actions following a Medicare & Medicaid contract for national coverage.
The company is also facing flak for a failed Protect II study undertaken in 2010. The trial was supposed to set a low threshold for an enzyme implicated in heart attacks. Since this enzyme is released during atherectomy, some physicians who undertook aggressive atherectomies may have caused heart attacks during the trial, based on blood and liver enzyme levels.
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