The US Food and Drug Administration (FDA) has approved the Amplatzer Piccolo Occluder (Abbott), the first medical device to treat patent ductus arteriosus (PDA) in premature babies weighing as little as two pounds (907 g).
"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, director, congenital heart program, Cedars-Sinai's Smidt Heart Institute, Los Angeles, and principal investigator for the study that led to FDA approval, said in a news release from Abbott.
About 60,000 infants are born prematurely in the United States each year, and nearly 12,000 (1 in 5) will have a hemodynamically significant PDA that requires urgent treatment. PDA accounts for up to 10% of all cases of congenital heart disease.
The Amplatzer Piccolo Occluder is a self-expanding, wire-mesh, pea-sized device that is inserted with a catheter through the femoral vein in the thigh and guided to the heart where it is placed to seal the PDA.
"It is designed to allow the physician to insert it through the aortic or pulmonary artery, as well as to retrieve and redeploy the device for optimal placement. Because the device is deployed in a minimally invasive procedure, 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 procedure," the company said.
The safety and efficacy of the Amplatzer Piccolo Occluder was demonstrated in a trial that involved 50 babies with a PDA at eight centers across the United States and through additional experience with the device under a continued access protocol that involved 150 additional babies.
"Piccolo is a critical advancement in the standard of care for the most vulnerable of premature babies who may not be able to undergo surgery to repair their hearts," Michael Dale, vice president for Abbott's structural heart business, said in the release.
More information about the Amplatzer Piccolo Occluder is available online.
Cite this: FDA Approves Abbott's Amplatzer PDA Occluder for Preemies - Medscape - Jan 15, 2019.