September 16, 2019
Abbott Receives European Approval of Heart Devices for Babies and Children
September 17, 2019—Abbott has announced European CE Mark approval for its Masters HP 15-mm rotatable mechanical heart valve and Amplatzer Piccolo occluder. The devices are now available in Europe and other countries that recognize the CE Mark. The devices are already available in the United States.
According to the company, the Masters mechanical heart valve allows doctors to treat babies and toddlers in need of a mitral or aortic heart valve replacement. The Amplatzer Piccolo device, which is smaller than a pea, can be implanted in the tiniest babies (weighing as little as < 1 kg) to treat patent ductus arteriosus.
The 15-mm Masters 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 27 mm.
Prior to the availability of the new device size, surgeons could only replace an irreparable pediatric heart valve with a range of larger-sized valves, which could result in improper fit and complications. The Masters pediatric valve was approved in the United States in March 2018 and in Canada in October 2018.
Approved in the United States in January 2019, Amplatzer Piccolo 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. The device provides corrective treatment for premature infants and newborns who may be nonresponsive to medical management and at high risk to undergo surgery. 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, noted Abbott.
Mario Carminati, MD, Director of Pediatric and Adult Congenital Cardiology at IRCCS Policlinico San Donato in Milan, Italy, commented in the company's announcement, “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.”