Abbott has secured the US Food and Drug Administration (FDA) approval for its Amplatzer Piccolo Occluder to treat patent ductus arteriosus (PDA) in premature babies and newborns.
PDA is a common congenital cardiac defect that is characterised by an opening between two blood vessels leading from the heart, resulting in difficulty in breathing.
Of the 60,000 premature babies born each year in the US, approximately 12,000 have a haemodynamically significant PDA requiring urgent medical intervention.
The new minimally invasive, transcatheter is said to be specifically intended to treat premature babies and newborns with PDA.
A self-expanding wire mesh device, Amplatzer Piccolo Occluder can be used to seal the opening in the heart by inserting it through a small incision in the leg and guiding via vessels to the heart.
The device can be inserted through the aortic or pulmonary artery, as well as retrieved and redeployed.
Abbott said that the minimally invasive procedure used for the deployment of the device allows critically ill premature babies to be weaned from artificial respirator support soon after the procedure.
The FDA approval of the device is based on data obtained during the pivotal ADO II AS clinical trial performed in 50 PDA patients, aged more than three days, at eight centres in the US.
Furthermore, the safety and efficacy of Amplatzer Piccolo Occluder is said to be supported by additional experience under a continued access protocol involving 150 patients.
Abbott structural heart business vice-president Michael Dale said: “Piccolo is a critical advancement in the standard of care for the most vulnerable of premature babies who may not be able to undergo surgery to repair their hearts.
“Our mission is to develop life-changing technology to help people live better lives through improved health. This approval is another important step toward achieving our mission for the patients and physicians we serve.”
The company also holds approval for the Amplatzer Duct Occluder II device to treat larger size paediatric patients with PDA.
