Abbott has initiated a US pivotal clinical study evaluating the safety and effectiveness of a modified version of its Amplatzer device to correct patent ductus arteriosus—a common congenital heart defect that occurs in approximately 80,000 preterm infants in the USA each year.
The company, a press release reports, is developing the Amplatzer duct occluder II additional sizes (ADO II AS) device—which is already approved for use in Europe—with the goal of providing physicians with a nonsurgical treatment option for closing the PDA defect in newborns and preterm infants. The wire mesh device is placed non-surgically through a catheter inserted through the leg and guided through vessels to the heart, where it is placed to seal the duct. The new device is similar to the Amplatzer duct occluder II product, available in larger sizes, and it builds upon more than 15 years of clinical success for Amplatzer occluder therapies.
The study will enrol approximately 50 patients at up to 10 centres across the USA. The first seven patients were enrolled at Le Bonheur Children’s Hospital in Memphis, USA, and treated by Shyam Sathanandam, associate professor at the University of Tennessee (USA).
Principal investigator for the study, Evan Zahn (Guerin Family Congenital Heart Program and director of the Division of Pediatric Cardiology at the Cedars-Sinai Heart Institute, Los Angeles, USA), says: “Patent ductus arteriosus is one of the most common heart defects, accounting for 5 to 10 percent of all congenital heart disease. Surgery has many risks in this delicate population and a minimally invasive approach is desperately needed.”
Patent ductus arteriosus is a life-threatening vascular pathway, or duct, in the heart that remains open due to failure of the foetal duct to close after birth. The duct, which serves as a bridge between blood vessels and is located between the main two arteries exiting the heart, is present in normally developing foetuses and typically seals itself after birth. In some cases, primarily in premature babies, the PDA fails to spontaneously close, which can result in serious difficulty breathing and inability to feed — two critical tasks for newborn babies.
If successful, the US trial results will support Abbott’s application for FDA approval for paediatric use in the USA.