FDA Approves Smallest Mechanical Heart Valve

Regular Walking Lower the Risk of Heart Failure

The FDA approved the world’s smallest mechanical heart valve designed for mitral or aortic valve replacement in infants

Conventionally surgeons used larger-sized devices to replace a pediatric heart valve that could not be repaired. These Large mechanical heart valves are not suitable due to the smaller size of children’s hearts. Abbott, healthcare company designed the Master HP 15mm rotatable mechanical heart valve for newborns and infants. Mechanical heart valves mimic the valve of a healthy heart, opening and closing with each beat to enable proper blood flow through the organ.

According to report, Congenital heart defects (CHD) affect around 40,000 newborns in the U.S annually. The clinical trials carried out for approval of the device involved 20 paediatric patients aged five years or younger, who were suffering from diseased or damaged heart. 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 pediatric mechanical heart valve provides surgeons with a much-needed option for treating these vulnerable, high-risk children.”

Three-year old infant, Sadie Rutenberg was the first infant to undergo the treatment in the clinical trial. She was suffering from fast breathing and stopped gaining weight due to a congenital heart problem. “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 pediatric heart valve is a life-changing technology for the smallest pediatric patients, giving them a better chance at a long, healthy life with a fully functioning heart.”

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