FDA clears minimally invasive circulatory-support device for use during cardiac interventions

Shelley Wood

June 03, 2008

Rockville, MD - The FDA has granted marketing clearance to Abiomed's Impella2.5 cardiac-assist device [1]. The device, which can be implanted percutaneously via the femoral artery into the left ventricle, is used for partial circulatory support for up to six hours.

The pump can deliver up to 2.5 liters of blood per minute from the left ventricle into the ascending aorta, "providing the heart with active support in critical situations," a press release states.

Evidence supporting the device approval comes in part from patients undergoing high-risk PCI in the PROTECT 1 trial.

In PROTECT 1, patients who underwent PCI with circulatory support using the Impella device had twice the expected in-hospital survival and significant improvements in ejection fraction from baseline. According to the press release, there are over 40 peer-reviewed papers about the device. The company is currently conducting two pivotal US studies comparing the Impella 2.5 with its intra-aortic balloon pump, which already has FDA marketing clearance.

Previously approved in Europe, the Impella has been used in over 1500 patients outside the US. Abiomed acquired the Impella 2.5 technology in 2005 when it took over Impella CardioSystems AG.

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