The FDA has approved the world’s smallest mechanical heart valve designed for mitral or aortic valve replacement in babies and toddlers.
Heart Valve
Designed by healthcare company Abbott, the Master HP 15mm rotatable mechanical heart valve is the only product designed for newborns and infants.
Mechanical heart valves work by mimicking the valve of a healthy heart, opening and closing with each beat to enable proper blood flow through the organ.
Before this product, surgeons could only use larger-sized devices to replace a paediatric heart valve that could not be repaired. Larger mechanical heart valves are often not suitable due to the smaller size of children’s hearts.
Congenital heart defects (CHD) affect around 40,000 newborns every year in the US.
Kirk R. Kanter, professor of surgery and director of the Heart Transplant Program at Children's Healthcare in Atlanta at Emory University School of Medicine, said: “In my practice, I want to be able to provide a treatment option that works for a critically ill child when a larger-sized valve may not be suitable. The approval of this smaller paediatric mechanical heart valve provides surgeons with a much-needed option for treating these vulnerable, high-risk children."
The approval of the Masters HP 15mm rotatable mechanical heart valve was based on the results of a clinical trial which enrolled 20 paediatric patients aged five years or younger who had a diseased, damaged or malfunctioning heart.
"There's an urgent need for the smallest babies and children who need a suitable replacement valve in order to survive," said Michael Dale, vice president of Abbott's structural heart business. "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.”
Sadie Rutenberg was only a few months old when her breathing became fast and she stopped gaining weight and eating well due to a congenital heart problem. Now three-years old, she was the first infant to undergo the treatment in the clinical trial.
Lee'or Rutenberg, Sadie's father, said: “When we were told that Sadie would need surgery right away, and was a candidate for a new clinical trial of a heart valve sized for her small body, we were willing to try it to hopefully save her life. When the doctor came out of surgery and told us the surgery was a success – as a parent, it's a moment I'll never forget. The valve saved Sadie's life."