United States Pivotal Study Begins for Abbott's Amplatzer Device to Treat Patent Ductus Arteriosus in Newborns
August 30, 2017—Abbott Vascular announced that it has initiated a United States pivotal clinical study evaluating the safety and effectiveness of a modified version of its Amplatzer device to correct patent ductus arteriosus (PDA).
Abbott is developing the Amplatzer Duct Occluder II Additional Sizes (ADO II AS) device with the goal of providing physicians with a nonsurgical treatment option for closing the PDA defect in newborns and preterm infants. The transfemoral, transcatheter procedure places the wire mesh device in the heart to seal the duct.
According to the company, the new ADO II AS device has been approved for use in Europe. It is similar to the Amplatzer Duct Occluder II product, available in larger sizes. The technology builds upon more than 15 years of clinical experience with Amplatzer occluder therapies, noted that company.
Investigators in the ADO II AS clinical trial will enroll approximately 50 patients at up to 10 centers across the United States. If successful, the trial results will support Abbott's application for US Food and Drug Administration approval for pediatric use in the United States.
The ADO II AS trial is a single-arm, prospective, multicenter, nonrandomized clinical investigation designed to characterize the safety and effectiveness of the ADO II AS device in patients with a PDA who are more than 3 days old. Coprimary endpoints are the rate of major complications through 180 days after an attempted implant, and the rate of effective closure of the ductus arteriosus among patients with a successful implant at 6 months. The secondary endpoint is the rate of significant obstruction of the pulmonary artery or aorta through 6 months.
The first seven patients were enrolled in the trial at Le Bonheur Children's Hospital in Memphis, Tennessee, and treated by Shyam Sathanandam, MD.
Evan Zahn, MD, Principal Investigator of the study, commented in Abbott's announcement, "PDA is one of the most common heart defects, accounting for 5% to 10% of all congenital heart disease. Surgery has many risks in this delicate population and a minimally invasive approach is desperately needed." Dr. Zahn is Director of the Guerin Family Congenital Heart Program and Director of the Division of Pediatric Cardiology at the Cedars-Sinai Heart Institute in Los Angeles, California.