FDA approves world’s first device for treatment of premature babies and newborns with an opening of their hearts

A recent press release by Abbott announced that the FDA approved the world’s first medical device that can be implanted into babies who need corrective treatment. 

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Editor’s Note: This article originally appeared on Abbott’s website

Abbott (NYSE: ABT) today announced the U.S. Food and Drug Administration (FDA) approved the Amplatzer Piccolo™ Occluder, the world’s first medical device that can be implanted in the tiniest babies (weighing as little as two pounds) using a minimally invasive procedure to treat patent ductus arteriosus, or PDA. The Amplatzer Piccolo, a device even smaller than a small pea, now offers hope to premature infants and newborns who need corrective treatment, and who may be non-responsive to medical management and high risk to undergo corrective surgery.

One of the most common congenital heart defects occurring in premature babies, PDA is a potentially life-threatening opening between two blood vessels leading from the heart. This channel, which is present in normally developing fetuses, is important prior to birth to allow oxygen-rich blood from the mother to circulate throughout the fetus’ body. For most infants, the pathway, or duct, seals itself shortly after birth. In some cases, primarily in babies born prematurely, the PDA fails to spontaneously close, which can make it difficult for babies to breathe normally due to increased blood flow to the lungs. PDA accounts for up to 10 percent of all congenital heart disease. Click here to continue>>

 

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