Pediatric Trial Begins for St. Jude Medical's Amplatzer Duct Occluder II AS for Closure of Small Patent Ductus Arteriosus

October 18, 2016—St. Jude Medical, Inc. announced the launch of the ADO II AS (Amplatzer Duct Occluder II Additional Sizes) pediatric clinical trial. The United States investigational device exemption (IDE) clinical trial will evaluate the safety and effectiveness of the St. Jude Medical Amplatzer Duct Occluder II AS, which is designed for closure of the small patent ductus arteriosus. 

According to the company, the ADO II AS IDE trial will enroll a maximum of 50 patients at up to 10 sites nationwide. Patients in the trial will be enrolled within two study groups: (1) a minimum of 15 patients ≤ 2 kg (approximately 4.4 pounds); and (2) a minimum of 25 patients > 2 kg.

St. Jude Medical stated that the ADO II AS device conforms to the smallest ducts and achieves complete closure from a pulmonary or aortic artery approach. Data collected during the ADO II AS trial across all trial sites will be used to support a premarket approval submission of the device to US Food and Drug Administration. The ADO II AS device is currently approved for use in more than 50 countries outside the United States, advised the company.

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, California, is national investigator for the ADO II AS trial. In the company’s announcement, Dr. Zahn commented, “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. 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.”