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Edwards Lifesciences

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FDA clears Edwards' expandable pediatric heart valve, the Autus

The FDA has approved Edwards' Autus Size-Adjustable Valve, an artificial pulmonary valve for children born with congenital heart defects. Unlike previous valves, it can be implanted small, starting at 13 millimeters, and later expanded inside the body using a balloon catheter up to 22 millimeters as the child grows, avoiding repeated replacement surgeries.