The U.S. Food and Drug Administration (FDA) has granted approval for the first heart valve prosthesis designed for children that has the capability to change size according to the child's growth.
This new pulmonary artery artificial valve is called the Autus Size-Adjustable Valve and was developed by Autus Valve Technologies, a subsidiary of Edwards Lifesciences. Initially, the valve can be implanted with a diameter of 13 millimeters, which meets the needs of preschoolers.
Subsequently, using a balloon catheter, it can be gradually expanded up to 22 millimeters, comparable to the size of the valve used in adult patients. A key difference of this device is the composition of its leaflets: unlike existing prostheses that use animal materials, the Autus leaflets are made of polymer material and secured on a metal frame.
This medical device is specifically designed to assist children suffering from congenital pulmonary valve defects.