Abbott Wins FDA Approval for World’s First Implant for Preemies and Newborns with Congenital Heart Defect

By MedTech Intelligence Staff

The device can be implanted in babies weighing as little as two pounds.

Today Abbott announced that it received FDA approval for the world’s first implant for premature infants and newborns who need corrective treatment for a common congenital heart defect. Smaller than a “small pea”, the Amplatzer Piccolo Occluder is a self-expanding wire mesh device intended to treat patent ductus arteriosus (PDA), an opening between two blood vessels leading from the heart that can cause increased blood flow to the lungs, making it hard for a baby to breathe.

The device can be implanted in babies weighing as little as two pounds. “This approval is a potentially life-saving advance for the very smallest premature infants that will help us treat these delicate babies who might otherwise not be able to survive,” said Evan Zahn, M.D., director of the Congenital Heart Program at Cedars-Sinai’s Smidt Heart Institute, and principal investigator for the study that led to FDA approval, in an Abbott press release.

The Amplatzer Piccolo Occluder is inserted through the aortic or pulmonary artery. From there, it is guided through vessels to the heart where it is implanted to seal the heart’s opening. This minimally invasive process allows premature babies who are very ill to be weaned from artificial respirator support “soon after the procedure,” according to the Abbott release.

Details and safety information about the occluder is available on Abbott’s website.

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