The US Food and Drug Administration (FDA) has approved Abbott’s Masters HP 15mm mechanical heart valve, which can treat paediatric patients requiring mitral or aortic valve replacement.
Developed specifically for newborns and infants, the new rotatable, bileaflet Masters heart valve is smaller and offers an alternative to larger devices that are not considered suitable for babies’ hearts.
When functioning correctly, the mitral and aortic valves of the heart work sequentially to move blood through the organ and supply oxygen-rich blood to the body.
This process is important for the heart to function properly and any alteration from the normal working of the valves could result in life-threatening organ failure.
Mechanical valves are designed to mimic a healthy heart valve, opening and closing with each heartbeat and allowing proper blood flow through the vital organ.
Abbott structural heart business vice-president Michael Dale said: “There’s an urgent need for the smallest babies and children who need a suitable replacement valve in order to survive.
“Abbott’s new mechanical paediatric heart valve is a life-changing technology for the smallest paediatric patients, giving them a better chance at a long, healthy life with a fully functioning heart.”
Before the approval of the new heart valve, the FDA reviewed findings from a clinical trial that involved paediatric subjects aged five years or below and had a diseased, damaged or malfunctioning heart valve.
The first implantation during the trial was carried out at the Seattle Children’s Hospital Heart Center, US.
