‘This could be transformative’: Surgeon performs first US implant of heart valve still under FDA review
A care team at C.S. Mott Children’s Hospital, part of University of Michigan Health, has made a bit of history by performing the first implant in the United States of a new-look pulmonary valve for pediatric patients.
The size-adjustable Autus Valve was originally developed by Autus Valve Technologies, which Edwards Lifesciences bought in February for $128.9 million. It was designed to grow with children as they age—clinicians can expand it with a minimally invasive balloon procedure—to keep them from undergoing multiple surgeries. The U.S. Food and Drug Administration (FDA) has not yet fully cleared the device, but it is closely watching the results of a select number of procedures performed throughout the United States.
The implant in question was performed on a six-year-old child from Michigan. Jennifer Romano, MD, MS, a heart surgeon with C.S. Mott Children’s Hospital, professor of cardiac surgery with the University of Michigan and former president of the Society of Thoracic Surgeons, led the implant procedure.
“This valve is a game changer,” Romano said in a statement. “Typically, we give these children a temporary fix, knowing they will need more surgeries down the road. “Now, we may be giving a child a valve that could potentially last them a lifetime. This could be transformative.”
C.S. Mott Children’s Hospital is one of a small number of facilities actively enrolling patients to receive this new valve. Each patient receiving one of these valves will be followed for many years.
“This effort required extraordinary collaboration across our congenital heart center, from identifying the right patients to coordinating the procedures and supporting families,” added Richard Ohye, MD co-director of the Congenital Heart Center at C.S. Mott Children’s Hospital. “Every part of the team came together to make this opportunity possible for our patients.”
Once the FDA does approve this device, Edwards Lifesciences will be able to make it available throughout the United States.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.