Amplatzer Piccolo Occluder clinical trial for percutaneous closure of the patent ductus arteriosus in patients ≥700 grams.
Shyam K SathanandamDan GutfingerLaura O'BrienThomas J ForbesMatthew J GillespieDarren P BermanAimee K ArmstrongShabana ShahanavazThomas K JonesBrian H MorrayToby A RockefellerHenri JustinoDavid G NykanenEvan M ZahnPublished in: Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions (2020)
This study supports the safety and effectiveness of the Amplatzer Piccolo Occluder, particularly in patients between 700 g and 2 kg where there is currently a significant unmet need in the United States. ClinicalTrials.gov identifier: NCT03055858.