Abbott begins Amplatzer device’s US study for heart defect in newborns
Abbott has started a clinical study to evaluate its Amplatzer Duct Occluder II Additional Sizes (ADO II AS) device developed for correction of patent ductus arteriosus (PDA) in premature and newborn infants in the US.
PDA is a common congenital defect of the heart's vascular pathway that remains open because of the foetal duct’s failure to spontaneously close after birth, resulting in breathing difficulties or the inability to feed.
Being developed to offer a nonsurgical treatment option for the PDA defect closure, ADO II AS is placed through the leg using a catheter insertion.
The wire mesh device is guided through vessels to the heart and positioned in a way to seal the duct.
Abbott structural heart business vice-president Michael Dale said: "This modified Amplatzer device has been designed with our youngest and tiniest patients in mind.
"These smaller sizes may offer physicians greater flexibility to hopefully help these infants live healthy, normal lives."
The single-arm, prospective, multicentre, non-randomised clinical investigation ADO II AS trial will evaluate the safety and effectiveness of the device in up to 50 patients aged more than three days at approximately ten sites.
Co-primary endpoints of the trial include the rate of major complications through 180 days following an attempted implant and the rate of effective closure of the ductus arteriosus at six months in subjects with a successful implant.
The secondary endpoint is the amount of significant obstruction of the pulmonary artery or aorta after six months.
ADO II AS is already approved in Europe and the latest trial is expected to support its application to secure approval from the US Food and Drug Administration (FDA) for treating paediatric patients in the country.