FDA

SUMMARY BOX: FDA weighs broader use of heart valve

AP News
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Posted: Jun 11, 2012 3:27 PM
SUMMARY BOX: FDA weighs broader use of heart valve

ALTERNATIVE THERAPY: The Food and Drug Administration said that a minimally invasive heart valve from Edwards Lifesciences worked about as well as traditional surgery in frail patients who may be too stick to survive open-heart procedures.

MORE PATIENTS: Edwards' Sapien valve can be threaded into place through an incision in the leg. The FDA is reviewing the device for patients who are eligible, but still face health risks from surgery.

STROKE CONCERN: The FDA will ask experts about side effects seen with the valve, including strokes. The FDA is not required to follow the group's advice, though it often does.