The FDA approved a heart valve that can be widened as a child grows

An implanted heart valve stays the same size while the child it was implanted in keeps growing. For children born with pulmonary valve disease, outgrowing a valve often means repeat open-heart surgery.

On October 1, the FDA approved the Autus Size-Adjustable Valve, which is designed to grow with the child. It starts at about 13 millimeters across and can be widened to 22 millimeters with a balloon catheter, a thin tube with an inflatable tip. That expansion takes the place of a replacement in open surgery. Its flaps, called leaflets, are made of a synthetic polymer.

The approval rests on a trial of 62 children at 12 sites. At six months, the first 60 had acceptable blood flow with no more than mild leakage, and there were no deaths, strokes, or clot complications. Three valves had fractures in their frames, and two had leaflets that moved less than they should. None of those children had symptoms.

Six months is a short window for a device meant to last through childhood, and doctors have limited experience so far with actually widening the valve. Studies of how well it holds up over the longer term are still underway.