The United States has approved the AUTUS pediatric heart valve, which doctors can expand as a child grows. This is an important step in pediatric cardiac surgery: in some cases, the technology may make it possible to avoid another open-heart operation.
The valve is implanted surgically and, if necessary, expanded using a catheter with a small balloon. Its leaflets are made of polymer — it is the first heart valve with polymer leaflets to be approved by the US Food and Drug Administration.
The study included 62 children who received the new valve. As their bodies grew, two patients needed their prostheses expanded, and doctors were able to do this without another open-heart operation. The device’s durability will now be assessed in a long-term follow-up study planned to last ten years.
