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Abiomed cleared to sell new heart pump

The product is a “game-changer,” expected to boost Abiomed’s share in the US market for heart pumps, an analyst says. The product is a “game-changer,” expected to boost Abiomed’s share in the US market for heart pumps, an analyst says.
By Robert Weisman
Globe Staff / September 11, 2012
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Danvers cardiac device maker Abiomed Inc. has won federal approval to sell a new heart pump that is less invasive and delivers greater blood flow than a similar model it now markets.

Abiomed said Monday that its Impella CP pump was approved by the Food and Drug Administration under the agency’s 510(k) clearance process, which allows companies to skip clinical testing of medical devices that are considered “substantially equivalent” to those already on the market.

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