The findings from the trial demonstrated the Amplatzer Piccolo device’s effectiveness and safety in closing a potentially life-threatening hole in the heart, known as a patent ductus arteriosus (PDA), in new-born babies.
A self-expanding, wire mesh device, Amplatzer Piccolo is inserted through a small incision in the leg and guided to the heart through vessels, before being placed to close the PDA.
According to the company, the device is the first and only minimally invasive transcatheter treatment in the world that is approved for sealing a PDA in premature babies with the congenital heart defect.
Abbott structural heart business senior vice-president Michael Dale said: “There are thousands of stories of infants in need that inspire us to continue innovating to help the youngest and most vulnerable babies.
“We realise just how important our commitment to restoring health is when we hear about paediatric patients who can begin living their best lives thanks to devices like our Amplatzer Piccolo Occluder.”
In the study, the Amplatzer Piccolo device showed a high survival rate of 95.5%, without any deaths related to the procedure and complete closure of PDA in almost all patients.
It also demonstrated a high implant success rate of 95.5%.
Additionally, the study found low device-related serious adverse event rates after the procedure.
An additional benefit of Amplatzer Piccolo is that its minimally invasive approach reduces the need for infants to undergo riskier surgical procedures.
Last month, Abbott’s Proclaim Plus spinal cord stimulation (SCS) system with FlexBurst360 therapy received US Food and Drug Administration (FDA ) approval.