weighing as little as 2 pounds.
PDA is a life-threatening opening between two blood vessels leading from the heart and commonly occurs in premature infants, with about one in five infants born prematurely having a hemodynamically significant PDA. The Amplatzer Piccolo Occluder is a self-expanding, wire mesh device that is minimally invasive and is the first device approved for use in very-low-birth-weight infants.
FDA approval was based on results of the ADO II AS trial, which evaluated the device in 50 patients with PDA who were older than 3 days. In addition, the safety and efficacy of the Amplatzer Piccolo Occluder was supported by a continued access protocol involving 150 more patients.
“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,” said Evan Zahn, MD, principal investigator of ADO II AS and director of the congenital heart program at Cedars-Sinai’s Smidt Heart Institute in Los Angeles.
Find the full press release on the Abbott website.