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FDA favors innovative heart valve for the frail

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WASHINGTON (AP) — Federal health scientists say the first

artificial heart valve designed to be implanted without major

surgery appears to help patients who are too frail to undergo

chest-opening surgery.

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The Food and Drug Administration has posted its review of a highly

anticipated heart valve from Edwards Lifesciences, which can be

threaded into place through one of the body’s major arteries.

Cardiologists hope this approach could offer a new option for old,

sickly patients who cannot undergo the more invasive open heart

surgery, which has been used to replace valves for

decades.

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FDA says more patients who received Edwards’ valve were living

after one year than those who did not receive the device in a

company study. However, scientists are also concerned about higher

rates of stroke and bleeding in the brain.

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