WASHINGTON — The Food and Drug Administration has approved a heart pump for patients with severe heart failure who cannot receive a transplant.
Regulators say they cleared Thoratec's HeartMate II, a battery-powered device that is implanted in the chest, where it helps the heart's lower left chamber pump blood throughout the body.
FDA says it approved the HeartMate II based on a company study showing 46 percent of patients implanted with the device were still alive two years later. The device is a smaller version of the company's original HeartMate model.
FDA previously approved HeartMate II as a temporary treatment for patients awaiting transplant.
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