The first-of-its-kind valve is designed to expand as the child grows, reducing the need for repeat open-heart surgeries. It’s also the first artificial heart valve approved in the United States with polymeric material leaflets rather than animal-derived tissue leaflets.
“For decades, Edwards has worked to address the needs of structural heart patients with complex conditions, Edwards Lifesciences CEO Bernard Zovighian said in the announcement. “The Autus valve represents a meaningful advancement for children who have historically had limited treatment options. Our commitment extends beyond innovation to generating clinical evidence and collaborating with physicians, medical societies and patient groups to help address the evolving needs of patients with congenital heart disease.”