St. Louis

The study evaluates the Renata Minima Stent System in treating pulmonary artery stenosis and aortic coarctation in neonates, infants, and small children. It is a post-approval, single-arm, prospective, multi-center, open-label study conducted in the United States to continue assessing the device's performance and collect real-world outcome data. Participants will receive treatment with the Minima Stent System, which is designed for patients weighing at least 1.5 kg. The study involves at least 100 subjects, with follow-up visits occurring immediately after the initial implant procedure, during any subsequent re-dilation procedures, annually, and at additional standard care visits determined by the implanting physician. The study monitors key data related to the device and procedure. Participants will be assessed at each follow-up visit through data collection used for analysis. Researchers will measure the rate of acute device success immediately after implantation and monitor participants for freedom from procedure- or device-related serious adverse events following the procedure. Follow-up will continue through 5 years post-implant to ensure long-term monitoring of safety and device performance.