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Medical Devices / Submissions and Approvals

FDA Approves Abbott’s Premie Heart Opening Treatment

Jan. 18, 2019
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The FDA approved Abbott’s Amplatzer Piccolo occlude, a device that can be implanted in babies weighing as little as two pounds to treat patent ductus arteriosus.

The minimally-invasive device, which is smaller than a pea, is able to treat the life-threatening opening between two blood vessels leading from the heart that can occur, most often in babies born prematurely.

The self-expanding, wire mesh device is inserted in the baby via a small insertion in the leg and directed through vessels to the heart, where it is placed to seal the opening.

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