The FDA has approved the wold’s smallest mechanical heart valve which can be used to repair congenital heart defects in children. Abbott’s Masters HP 15mm rotatable mechanical heart valve is about the size of a dime and addresses an unmet medical need in the pediatric cardiothoracic surgery space.
“While larger replacement heart valves have been approved for years, there is an unmet need in young pediatric patients, especially newborns and infants, with congenital valve defects who may be too small to use currently-marketed heart valves,” said Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health.
It’s estimated that about 40,000 children in the US are born with a congenital heart defect each year. Sometimes underperforming valves can be surgically repaired, however some children require a full replacement of the heart valve. As no replacement valve this small has existed until now, surgeons have historically been forced to use larger, adult-sized valves which were not designed for pediatric patients.
“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,” said Dr. 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, which was the top enrolling site for the trial that led to approval of this new treatment option. “The approval of this smaller pediatric mechanical heart valve provides surgeons with a much-needed option for treating these vulnerable, high-risk children.”
The FDA approved Abbott’s mechanical heart valve based on a clinical trial of 20 patients under the age of five with poorly-functioning heart valves. The mechanical heart valve can be used as a replacement for both mitral or aortic valves.
“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.”