Global healthcare MNC Abbott has announced that it has received USFDA clearance and CE Mark for its Amplatzer Piccolo Delivery System, designed to work with the company’s Amplatzer Piccolo Occluder to treat premature babies with a hole in the heart known as patent ductus arteriosus (PDA). 

 

The system is intended for some of the tiniest patients—premature infants weighing as little as two pounds.

 

A PDA is an opening between two blood vessels in the heart that should close after birth. If it remains open, extra blood flows to the lungs, making it difficult for babies to breathe.

 

"Abbott's new Amplatzer Piccolo Delivery System is a transformative step forward in how we treat PDA in premature infants," said Evan Zahn, professor of cardiology and pediatrics and director of the Guerin Family Congenital Heart Program at Cedars-Sinai Medical Center in Los Angeles. 

 

"The new delivery system simplifies the implant procedure because only one catheter is needed instead of multiple, and a shorter and softer design allows for more precise device positioning in these tiny babies. Doctors can treat this group with more confidence, reducing the risk of adverse events and improving the long-term outlook for this uniquely vulnerable patient population."

 

The Amplatzer Piccolo Occluder, smaller than a pea, is the world’s first and only minimally invasive, transcatheter treatment approved to close a PDA in premature infants. The device is inserted through a small incision in the leg and guided to the heart using the new delivery system, where it seals the opening. The Piccolo Occluder itself received FDA approval and CE Mark in 2019.

 

"We designed the Amplatzer Piccolo Delivery System based on feedback from leading physicians across the world to make PDA closure procedures even safer and easier," said Sandra Lesenfants, senior vice president of Abbott's structural heart business. 

 

"With the Amplatzer Piccolo Occluder, which is the world's smallest heart device, and now with the new delivery system to complement it, we're continuing to advance how we meet the needs of our tiniest patients with structural heart disease."

 

Abbott’s pediatric heart portfolio also includes the Masters HP 15mm, the world’s smallest mechanical heart valve, and the HeartMate 3 heart pump, approved for pediatric patients. The company continues to develop life-saving devices aimed at reducing complications and enabling physicians to confidently treat the youngest and tiniest patients.