No Panel Needed To Expand Impella Into Cardiogenic Shock, Abiomed Says
This article was originally published in The Gray Sheet
Abiomed and FDA have agreed to an indication that would allow the firm to market its percutaneous Impella pumps for circulatory support of patients in cardiogenic shock following acute myocardial infarction or cardiac surgery, and no advisory panel will be needed before FDA makes an approval decision, the company says.
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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.
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