Abbott Announces European Approval of Two Life-Saving Heart Devices for Babies and Children

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– World’s smallest pediatric treatments pioneered by Abbott address critical needs for the most vulnerable patients: babies and children born with common congenital heart defects
– Includes pediatric mechanical heart valve and first minimally invasive device to treat premature babies and newborns born with an opening in their heart

Abbott (NYSE: ABT) today announced approvals in Europe for two of its life-saving pediatric devices. The Masters HP™ 15mm rotatable mechanical heart valve and the Amplatzer Piccolo™ Occluder have received CE Mark and are now available in Europe and other countries that recognize CE Mark. The new treatments, already available in the U.S., offer young pediatric patients and their families hope when no other suitable treatment option may exist.

Congenital heart defects (CHD) affect approximately 36,000 births in the European Union each year.i The Masters valve is the world’s smallest mechanical heart valve and allows doctors to treat babies and toddlers in need of a mitral or aortic heart valve replacement. The Amplatzer Piccolo is smaller than a pea and is the world’s first medical device that can be implanted in the tiniest babies (weighing as little as under one kilogram) to treat patent ductus arteriosus, or PDA, a potentially life-threatening opening in the heart. These life-saving devices for certain congenital heart defects are the first and only devices of their kind.

“Devices like these are among the best examples of our promise at Abbott to help people live their fullest lives – in this case, young babies and children for whom these treatments are nothing short of miraculous,” said Michael Dale, vice president of Abbott’s structural heart business. “While the children who benefit from these therapies represent a very small segment of the total population with structural heart disease, these advanced technologies enable physicians to treat vulnerable pediatric patients who otherwise have limited options.”


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