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Abiomed gets FDA OK for Impella device

Awardee Story Abiomed gets FDA OK for Impella device
Date: Sep 10, 2012
Author: Patricia Resende
Source: Mass High Tech ( click here to go to the source)

Abiomed Inc. (Nasdaq:ABMD) received approval by the U.S. Food and Drug Administration (FDA) for a new catheter-based Impella device that provides four liters of blood per minute.

The 510 (k) clearance by the FDA allows for the Impella CP to have the same indications for use as the Impella 2.5. Cambridge-based Abiomed plans to have a controlled launch with top cardiac hospitals in the U.S., with full commercial availability by the fourth quarter of fiscal 2013, the company said Monday. The new heart pump will be marketed as the Impella Cardiac Power in the U.S. and outside the U.S. as Impella cVAD, for which it received EU approval in April.

The clinical community has been anxiously anticipating the arrival of this new Impella pump. The Impella CP promises a substantial amount of cardiac power, can be inserted quickly, and is ideal for patients that require more hemodynamic support, said John Lasala M.D., medical director of Washington University School of Medicine in St. Louis. It is exciting for physicians to be able to provide this type of percutaneous support that represents approximately 80 percent of what a healthy heart can pump each minute.

The approval comes after Abiomed reported 2012 as its best year in the companys history thanks to total revenue of $126.4 million, up 25 percent from 2011 revenue of $101.2 million, for the year ending March 31, 2012.

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