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news.Abiomed, a provider of cardiovascular devices, has received 510(k) clearance from the FDA for its Impella 2.5 cardiac assist device.
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The Impella 2.5 is cleared for use under the 510(k) for partial circulatory support for periods up to six hours. The intra-aortic balloon pump (IABP) also has 510(k) clearance and approximately 110,000 are used each year in the US. Abiomed is currently conducting two US pivotal studies comparing the Impella 2.5 to the IABP.
This 510(k) clearance allows Abiomed to begin selling the device to the estimated 14,000 interventional cardiologists at approximately 1,700 heart hospitals in the US.
Michael Minogue, chairman, CEO and president of Abiomed, said: “FDA clearance of the Abiomed Impella 2.5 represents the next step in enabling heart recovery for patients in the US and will likely change the standard of care in the catheterization lab. The device seamlessly provides immediate, minimally invasive circulatory support for critical patients.”