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FDA APPROVES THE WORLD’S SMALLEST OCCLUDER

Jan. 14, 2019

The U.S. Food and Drug Administration (FDA) approved the world's first medical device that can be implanted in the tiniest babies (weighing as little as 700g) using a minimally invasive procedure to treat patent ductus arteriosus, or PDA. The occluder is even smaller than a small pea, creating hope for premature infants and newborns who need corrective treatment, and who may be non-responsive to medical management and a high risk to undergo corrective surgery.

This device is able to occlude a variety of duct sizes, or elongated ducts.

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