The FDA has approved the Minima stent system, the first device specifically designed for infants and young children with congenital heart defects. The innovative stent could help thousands of children avoid multiple open-heart surgeries as they grow up.
Every year, around 40,000 babies in the U.S. are born with congenital heart defects, often requiring stents to keep their blood vessels open, NBC News reported Oct. 17.
Traditionally, pediatric surgeons have had to modify adult-sized stents to fit the smaller hearts of infants, an inefficient practice that often makes it necessary for the child to have further surgeries as they get older.
Evan Zahn, MD, a pediatric cardiologist and chief medical officer at Renata, the company behind the Minima stent, told NBC News, that the new device is designed to grow with the child. It can be adjusted through a minimally invasive procedure, allowing for easier and safer management of heart conditions like aortic coarctation and pulmonary artery stenosis, he said.
Michael Argilla, MD, a pediatric cardiologist and director of the pediatric catheterization laboratory at NYU Langone Health in New York City told the news outlet, "The word game-chamger is thrown around a lot, but this stent really does change the frame of reference for a lot of our work, which is pretty amazing."