St. Jude Medical (NYSE:STJ) said today that it’s launching a pediatric clinical trial of a version of its Amplatzer cardiac implant for treating a congenital heart defect.
The 50-patient ADO II AS study is designed to enroll 2 patient cohorts: at least 15 patients weighing 4.4 lbs. (2kg) or less and at least 25 patients weighing more than that.
Little Canada, Minn.-based St. Jude said the ADO II AS device is designed to treat a common congenital heart defect called patent ductus arteriosus via pulmonary or aortic artery approach. The company said it plans to use data from the study to back a pre-market approval application with the FDA (the device is already approved in more than 50 other countries, St. Jude said).
The trial is St. Jude’s 2nd pediatric heart device study, following the Halo investigational device exemption trial of its Master HP valve, at 15mm claimed as the world’s smallest pediatric mechanical heart valve. It’s designed as a replacement for failing mitral valves in children with no other options.
“St. Jude Medical is continuing to build its legacy of innovation in the field of pediatric cardiology, and working to break the barriers to developing new CHD treatments so more children’s health conditions can be properly addressed,” Dr. Srijoy Mahapatra, vice president of clinical, medical and scientific affairs, said in prepared remarks. “We are passionate about helping kids thrive, along with creating medical solutions that save and improve their lives.”
“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,” added study investigator Dr. Evan Zahn of the 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.”
