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Impella 2.5 PMA Gives Abiomed Big Growth Potential For High-Risk PCIs

The approval, the first for a percutaneous hemodynamic support device, frees Abiomed's hand to market the miniature blood pump to a relatively broad patient population, analysts note.

FDA's PMA approval of Abiomed Inc.’s Impella 2.5 miniature blood pump system for circulatory support during certain high-risk percutaneous coronary intervention gives the company a strong hand to market its device to a relatively broad population including patients who previously were not candidates for high-risk PCI, analysts say.

Impella 2.5 is approved as a temporary ventricular support device to be deployed during high-risk percutaneous coronary interventions in hemodynamically stable patients with severe coronary artery disease and depressed left...

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