FDA Grants Premarket Approval To AbioMed Heart Pump

March 24, 2015 1:18 PM

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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 function who are undergoing high risk PCI but who are not candidates for surgical revascularization. The Impella 2.5 is delivered to the heart through ...

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