Abbott wins FDA approval for Amplatzer Piccolo occluder for neonates

The FDA granted pre-market approval for the Amplatzer Piccolo occluder made by Abbott (NYSE:ABT) to treat a congenital heart defect in neonatal infants as small as two pounds, the company said today.

The Chicago-area healthcare giant said Amplatzer Piccolo is a transcatheter, self-expanding, wire mesh device that’s inserted via the aortic or pulmonary artery to close a hole in the heart known as patent ductus arteriosus.

“Piccolo is a critical advancement in the standard of care for the most vulnerable of premature babies who may not be able to undergo surgery to repair their hearts,” structural heart VP Michael Dale said in prepared remarks. “Our mission is to develop life-changing technology to help people live better lives through improved health. This approval is another important step toward achieving our mission for the patients and physicians we serve.”

“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,” added Dr. Evan Zahn, of the Cedars-Sinai’s Smidt Heart Institute Los Angeles, who was principal investigator for the Amplatzer Piccolo pivotal trial.

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from MassDevice http://bit.ly/2AJr5kq