St. Jude Medical announced today that it has launched a pediatric clinical trial to evaluate the safety and effectiveness of the AMPLATZER Duct Occluder II AS, a device designed for closure of small patent ductus arteriosus (PDA).
Each year congenital heart disease affects 1.3 million babies worldwide. Nearly 25 percent of that group require surgery during their first year of life.
“The patients who would be eligible for this study are the tiniest and most fragile we care for—severely premature newborns who in many cases are critically ill from the presence of a patent ductus arteriosus (PDA),” said national investigator Evan Zahn, MD, director of the Guerin Family Congenital Heart Program in the Cedars-Sinai Heart Institute and Department of Pediatrics at Cedars‐Sinai Medical Center in Los Angeles. “The AMPLATZER Duct Occluder II AS will provide an experimental option to surgery. Surgery has many risks in this delicate population and a minimally invasive approach is desperately needed for this fairly common and often quiet serious problem.”
In 2007, the U.S. Congress passed the Pediatric Medical Device Safety and Improvement Act to prompt development of medical devices designed and engineered specifically for the pediatric patient population. Currently, many children are treated with adult-sized devices that are not ideal for ttheir iny hearts.