Each year, almost 12,000 underweight babies are born in the U.S. with an opening in their heart requiring medical intervention. The FDA has now approved a groundbreaking medical device to treat patent ductus arteriosus (PDA) that can be implanted in babies weighing as little as two pounds via a minimally invasive procedure.
The Amplatzer Piccolo Occluder (Abbott), which is smaller than a small pea, offers hope to premature infants and newborns who may not respond to medical management and are a high risk for heart surgery.
PDA, a common congenital heart defect in premature babies, is a potentially life-threatening opening between two blood vessels that lead from the heart. This passage, which is present in developing fetuses, allows the mother’s blood to circulate throughout the fetus’ body. Usually, the PDA closes up naturally before birth but in premature babies, it can fail to close, leading to breathing difficulties for the babies.
The Amplatzer Piccolo Occluder is a self-expanding, wire mesh device that can be inserted through the aortic or pulmonary artery. The physician inserts it through a small incision in the leg, guiding it through vessels to the heart, where it seals the opening. The device can also be retrieved and reinserted for optimal placement.
The FDA’s approval of Amplatzer Piccolo Occluder was based partly on results from the pivotal ADO II AS trial. The trial enrolled 50 patients with a PDA who were older than three days at eight centers across the U.S. The safety and efficacy of the device is further supported by additional data from a continued access protocol with 150 more patients.
Source: SeekingAlpha.com, January 14, 2019