Abbott said today that it won CE Mark approval for its Masters HP mechanical heart valve and Amplatzer Piccolo occluder.
The Masters HP is the world’s smallest mechanical heart valve (15mm) and is designed for implantation in the mitral or aortic position to mimic a healthy heart valve by opening and closing to facilitate blood flow through the heart.
The Amplatzer Piccolo occluder is a wire mesh device inserted in the leg and guided through vessels to the heart, designed to seal the opening in the heart found in patent ductus arteriosus.
The two devices are already available in the U.S. The Masters HP valve won FDA approval in March 2018, while the Amplatzer Piccolo received approval in January of this year.
“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,” VP of Abbott’s structural heart business Michael Dale said in prepared remarks. “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.”
“Seeing the youngest patients fight for their lives is harrowing, and finally having solutions that can offer a dependable treatment option to get these little ones out of the NICU and sent home with their families is a huge advance in our field,” added Dr. Mario Carminati, director of pediatric and adult congenital cardiology at IRCCS Policlinico San Donato in Milan.
Shares of ABT were up 1.2% to $84.37 per share in late-morning trading today.
See Full Article: Abbott wins CE Mark for pediatric heart devices – MassDevice
Written by: Sean Whooley
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