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Abbott’s Pediatric Cardiovascular Devices Gain CE Mark

The Abbott Park, IL-based company is bringing its Masters HP 15mm rotatable mechanical heart valve and the Amplatzer Piccolo Occluder to Europe. Both devices have FDA approval.

Abbott Laboratories is bringing two of its pediatric devices in the cardiology space to Europe. The Abbott Park, IL-based company has received CE mark for both the Masters HP 15mm rotatable mechanical heart valve and the Amplatzer Piccolo Occluder.

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. Until Abbott's device, surgeons could only use a range of larger-sized valves to replace a pediatric heart valve that could not be repaired, which could result in improper fit and complications. The Masters pediatric valve was approved in the U.S. in March 2018 and in Canada in October 2018.

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.

Abbott’s Amplatzer Piccolo, gained FDA approval earlier this year and is a self-expanding, wire mesh device that is inserted through a small incision in the leg and guided through vessels to the heart, where it is placed to seal the opening in the heart. Many of the premature babies who are critically ill in the neonatal intensive care unit are able to be weaned from artificial respirator support soon after the minimally invasive procedure.

"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, VP of Abbott's structural heart business, in a release. "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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