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FDA notes survival benefit with Edwards heart valve that does not require open heart surgery
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.
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.
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.