FDA greenlights Edwards’ expandable pulmonary valve for paediatric patients

Via a catheter Key takeaways Powered by Yahoo Scout. Yahoo is using AI to generate key points from this article. This means the info may not always match what’s in the article. Reporting mistakes helps us improve the experience. The Edwards Autus expandable pulmonary heart valve has received FDA approval for paediatric patients with congenital pulmonary valve disease, designed for initial implantation at around 13mm and expandable up to 22mm in diameter. Congenital heart defects affect around 1 in every 100 babies in the US, with approximately 4,200 children impacted each year, leading to potential pulmonary regurgitation and a need for valve replacement as they grow. The Autus valve's approval was based on a pivotal trial showing 100% of patients free from device-related complications through 30 days, with consistent outcomes at one year, demonstrating favourable valve performance and no reinterventions required through six months.