FDA Approves World's First Device for Treatment of Premature Babies and Newborns with an Opening in Their Hearts (a Common Congenital Defect)

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Jan 14, 2019
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- First and only minimally invasive, transcatheter treatment specifically approved for premature babies with a patent ductus, a life-threatening opening in their heart

- Nearly 12,000 very low birth weight babies are born in the U.S. each year with a persistent opening in their heart that requires medical intervention[1,2,3]

- Life-saving technology provides new and optimally-sized treatment option to address critical need for the tiniest newborns, including premature infants weighing as little as two pounds

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