The FDA has approved the Amplatzer Piccolo Occluder as a minimally invasive treatment option for patent ductus arteriosus (PDA) in newborns weighing as little as two pounds. According to its manufacturer, Abbott, it is the first such device in the world to be approved for babies so small.
"This approval is a potentially life-saving advance for the very smallest premature infants that will help us treat these delicate babies who might otherwise not be able to survive," Evan Zahn, MD, the director of the congenital heart program at Cedars-Sinai’s Smidt Heart Institute in Los Angeles, said in a press release. Zahn was the principal investigator of a 50-patient study which helped support the FDA approval.
PDA occurs when a duct between two blood vessels leading from the heart fails to seal before birth, leaving an opening. It accounts for up to 10 percent of all congenital heart disease and about 12,000 babies in the U.S. each year who are born with very low birthweight also have a hemodynamically significant PDA, according to Abbott.
But the self-expanding Amplatzer Piccolo is “smaller than a small pea,” the release stated, and can be threaded through an incision in the leg to the heart, where it’s used to seal the opening. Other devices in the Amplatzer Occluder family have already been approved for use in larger pediatric patients in the U.S., Europe and other countries.
Safety information for the Amplatzer Piccolo is available here.
Daniel joined TriMed’s Chicago editorial team in 2017 as a Cardiovascular Business writer. He previously worked as a writer for daily newspapers in North Dakota and Indiana.