Abiomed snags CE mark for Impella cVAD heart pump

Abiomed ($ABMD) is gearing up for a full European commercial launch of its Impella cVAD heart pump by this summer, now that it has obtained a CE mark for the device.

While the European market is a big win for Abiomed, it has yet to obtain clearance for the Impella cVAD in the U.S.

Still, adding more Impella pumps is a big part of Abiomed's bottom line. The company booked $32.2 million in revenue during its fiscal 2012 third quarter, up 18% from the same period the previous year. Of that number, $27.7 million reflected global Impella product revenue, itself up 31% from the fiscal 2011 third quarter, most of which was generated through U.S. sales, according to the company.

The pump is approved for use in the European Union in cardiology and cardiac surgery for up to 5 days, the company said. It is indicated for patients whose heart has a weakened left ventricle, low output syndrome or cardiogenic shock after an acute heart attack. EU surgeons will also be able to use the device as a cardiovascular support system during coronary bypass surgery.

The Danvers, MA-based company describes the Impella cVAD as being designed to give " temporary circulatory support via a minimally invasive, catheter-based pump" that's inserted under the skin without the need for surgery.

- here's the release

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The CE Mark for the system’s fourth iteration follows a July 2019 approval from the FDA.