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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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