The FDA approved the Autus Size-Adjustable Valve on October 2. It is the first heart valve designed to grow with a child. Here is why that matters.

Some babies are born with congenital pulmonary valve disease. The valve that controls blood flow from the heart to the lungs does not work properly. Doctors replace it with an artificial valve.

The problem is size. A valve that fits a toddler will be too small for a teenager. With fixed-size valves, children outgrow them. Each outgrowth can mean another open-heart surgery. Multiple surgeries carry risks and take a heavy toll on families.

The Autus valve starts at about 13 millimetres wide, small enough for a toddler. Later, doctors thread a small balloon through a blood vessel to widen it. It can expand up to 22 millimetres, close to adult size. Its leaflets use a synthetic material, a first for an FDA-approved valve. In a study of 62 children, all procedures succeeded with no deaths or strokes. Two children already had their valves widened without surgery.