Abbott has gone on to secure the US Food and Drug Administration – FDA and CE Mark approvals for its Amplatzer Piccolo delivery system, which is designed for premature infants that are diagnosed with patent ductus arteriosus – PDA.
The approval enables its use alongside the Amplatzer Piccolo occluders that are specifically tailored for infants with this kind of a congenital heart condition.
It is well to be noted that PDA is a condition that is characterized by an opening between two blood vessels within a newborn’s heart that does not close after birth as it actually should.
This opening, which is essential before birth in order to allow blood to bypass the lungs, can go on to cause complications if it remains open. These complications may include abnormal blood flow to the lungs as well as difficulty breathing.
Amplatzer Piccolo occluders is a minimally invasive and transcatheter device that is used for closing a PDA within premature infants.
The device gets inserted by way of a small incision in the leg and navigated through the vessels toward the heart through using the Amplatzer Piccolo delivery system. It seals the heart opening once it gets in place.
The occluder had in the past secured a CE Mark and also FDA approval in 2019.
Sandra Lesenfants, who is the structural heart business senior vice president from Abbott, went on to say that they designed the Amplatzer Piccolo delivery system based upon the feedback that came from leading physicians throughout the world so as to make PDA closure procedures much safer and easier.
She added that with the Amplatzer Piccolo occluder, which is indeed the smallest heart device in the world, and now due to the new delivery system to go with it, they are continuing to advance how they go ahead and meet the requirements for their tiniest patients having structural heart disease.
It is worth noting that Abbott’s range of pediatric heart treatments also goes on to include the Masters HP 15 mm mechanical heart valve along with the HeartMate 3 heart pump, which has gone ahead and secured approval for usage in pediatrics.
In November 2025, Abbott went ahead and entered a definitive agreement in order to acquire all the outstanding shares of Exact Sciences for a forecasted enterprise value of $23bn, hence marking its entry into the cancer diagnostics market.
