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Multicenter pivotal trial of the Minima stent for vascular stenosis in infants and young children.
2025-06-20
cardiovascular medicine
Title + abstract only
View on medRxiv
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BackgroundThe Minima Stent System is the first stent designed, tested, and FDA-approved for use in neonates, infants, and children. Our objective was to evaluate the safety and efficacy of Minima implantation for pulmonary artery stenosis (PAS) and coarctation of the aorta (CoA). MethodsMulticenter, single-arm, prospective, non-randomized trial. Primary endpoints included stenosis relief, freedom from device-related serious adverse events (SAEs) or surgical intervention through 6-months, and ma...
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