FDA Grants Premarket Approval To AbioMed Heart Pump

The FDA said today that it had approved Abiomed’s Impella 2.5 System. According to the company it is is the first hemodynamic support device to gain FDA premarket approval for use during high risk PCI procedures. The miniature blood pump is designed for temporary use in patients with severe symptomatic coronary artery disease and diminished (but stable) heart…

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FDA Approves New Heart Pump From Abiomed

Abiomed has announced that it received FDA approval for its Impella RP System, the first percutaneous single access heart pump that provides support to the right side of the heart. The approval, under a Humanitarian Device Exemption (HDE), is based on results of the single arm Recover Right study, in which 30 patients were enrolled. The overall survival…

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Buried Clinical Trial Data: The Dam Is About to Burst

Two important new developments may mean that many more researchers will soon be able to access and analyze data from many more clinical trials. … a preliminary report from the prestigious Institute of Medicine lends strong support to the open data movement. The IOM report states that investigators should be required to establish a data-sharing plan at the…

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DOJ Investigating Abiomed For Improper Marketing Of Impella Circulatory Support System

Cardiovascular device maker Abiomed announced that the US Attorney’s Office was investigating the company’s marketing and labeling of the Impella 2.5 circulatory support device. The announcement confirmed rumors that had been circulating for at least two weeks, though in the press release the company said it had been informed of the investigation on October 26….

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News Flash! Company Issues Incredibly Boring Press Release

Last week Abiomed issued a press release (reprinted below) that was about as dull as a press release can get. The main news of the press release was that the PROTECT II study testing the company’s Impella 2.5  circulatory support device had been published online in Circulation. The press release provides no details or information about…

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