Lifeline Ductus Arteriosus Stent for Ductal Patency

This study is being conducted to evaluate a medical device called the Lifeline Ductus Arteriosus Stent System. The main goal is to see if this stent is safe and effective for patients who need their ductus arteriosus to remain open, which is a critical condition in some heart patients, particularly infants with certain congenital heart defects. The researchers are gathering data to potentially gain approval from the Food and Drug Administration (FDA), which would help make this treatment more widely available and improve care for those with this specific medical need. Participants in the study will receive the Lifeline Ductus Arteriosus Stent as part of their treatment. This stent is a small device that is placed in the ductus arteriosus to keep it open. The study will monitor how well the stent works and any side effects that occur. Although the study does not explicitly mention risks or benefits, typically, such studies aim to ensure that the device is both effective in its function and safe for patients to use.