FDA approves first pediatric heart valve that grows with the child

The FDA has approved Edwards' Autus Size-Adjustable Valve, the first artificial heart valve that can be expanded after implantation using a balloon catheter. It can be implanted as small as 13 mm and expanded up to 22 mm, sparing children with congenital heart disease from repeated surgeries.

• Valve is implanted from 13 mm and expanded up to 22 mm, adult size
• Expansion is done post-surgery with a balloon catheter
• First valve with polymeric flaps instead of animal tissue
• About 4,200 US babies a year are born with pulmonary valve defects