Abbott recently announced the initiation of a pivotal clinical study based in the United States that will assess the safety and efficacy of a modified version of its Amplatzer device.
Amplatzer was created to correct a common congenital heart defect known as patent ductus arteriosus (PDA) that occurs in approximately 80,000 pre-term infants in the U.S. each year.
"Patent ductus arteriosus is one of the most common heart defects, accounting for 5 to 10 percent of all congenital heart disease," Dr. Evan Zahn, director of the Division of Pediatric Cardiology at the Cedars-Sinai Heart Institute in Los Angeles and principal investigator for the study, said. "Surgery has many risks in this delicate population and a minimally invasive approach is desperately needed."
A successful trial could lead to approval from the U.S. Food and Drug Administration. If that occurs, the product could be used by pediatricians across the country.
"This modified Amplatzer device has been designed with our youngest and tiniest patients in mind," Michael Dale, vice president of Abbott's structural heart business, said. "These smaller sizes may offer physicians greater flexibility to hopefully help these infants live healthy, normal lives."
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