Twin Approvals: Abbott bags CE Mark for its Mechanical Heart Valve and Occluder devices
ABBOTT PARK -- Abbott 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."
What is Masters HP 15mm Rotatable Mechanical Heart Valve?
Smaller than a 1c euro, at just 15mm the Masters valve is the first and only pediatric mechanical heart valve developed for newborns and infants and is now available in the European Union. The valve is a rotatable, bileaflet mechanical heart valve designed for implantation in the mitral or aortic position and is part of the Masters Series line, which now includes seven valves with diameter sizes ranging from 15 to 27mm.
When the tissues of the heart valve have a significant malformation or are too damaged and cannot be repaired to function properly, it may be necessary to replace the valve with a mechanical valve. A mechanical heart valve mimics a healthy heart valve, opening and closing with each heartbeat, permitting proper blood flow through the heart.
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 United States in March 2018 and in Canada on October 2018.