Developing very small devices that can be used for children is a significant challenge in the market. FDA is cautious to approve new devices into this market for vulnerable patients. But the efforts are needed to improve the health of babies, particularly those born with heart defects. Abbott’s reduced sized Amplatzer duct occluder II (ADO II) is one such device that was recently shown to be safe for very small children.
The device was developed by St Jude Medical (now Abbott Laboratories) and is used to treat patent ductus arteriosus. It works by closing the blood vessel that connects 2 major arteries. In healthy babies, the ductus arteriosus (DA) closes on its own within days following birth. If untreated, the defect can impair blood flow, leading to serious circulation problems including pulmonary hypertension or heart failure. It is found in roughly 0.02 to 0.006 percent of babies born at term and 20 percent to 60 percent of babies born prematurely.
The new research, which was supported by St. Jude Medical and published in the May 2017 issue of Catheterization and Cardiovascular Intervention, studied 192 patients between August 2008 and April 2011.
ADO I was designed for larger hearts and authors were able to implant the ADO II in smaller and moderate sized ducts in 93% of the children in the study. These smaller versions of the device are more suitable for use in premature babies and could spare the tiny patients from undergoing open-chest surgical closure of the ducts.
The researchers noted that this could mean faster approval for even smaller versions of the device. Such devices are available outside of the United States.
“This data is helping to push forward less invasive treatments for our tiniest and most vulnerable patients,” said Dr. Daniel Gruenstein, lead author of the study.
“They are the ones who are most at risk and who need a wide range of appropriately sized interventional tools,” said Gruenstein, who is associate professor of pediatrics and section chief of pediatric cardiology at the University of Chicago.
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