March 24th, 2015
FDA Grants Premarket Approval to AbioMed Heart Pump
Larry Husten, PHD
The FDA said on Tuesday 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 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) […]
January 29th, 2015
FDA Approves Right Percutaneous Single Access Heart Pump
Larry Husten, PHD
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 […]
September 21st, 2012
News Flash! Company Issues Incredibly Boring Press Release
Larry Husten, PHD
A dull press release and dull scientific paper may, in this case, signify genuine progress.
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