Abbott received FDA clearance for a new delivery system designed to simplify PDA closure in premature infants weighing as little as 2 lbs.
Abbott's CE Mark for its Amplatzer Piccolo Delivery System, a device designed to be used with the company’s Amplatzer Piccolo Occluder to treat premature infants with patent ductus arteriosus (PDA) (including babies weighing as little as 2 pounds), has received FDA clearance and CE Mark, according to a press release from the company.1
PDA is a congenital heart condition in which an opening between two blood vessels in an infant’s heart fails to close after birth.1,2 If the opening remains after delivery, blood flow is redirected to the lungs, making it difficult for affected infants to breathe normally. PDA is a particularly serious concern in premature babies, whose underdeveloped organs and small size can complicate both diagnosis and treatment.1
The delivery system was developed to simplify and refine how physicians perform minimally invasive PDA closure procedures in this population. According to Abbott, the Amplatzer Piccolo Delivery System is specifically engineered for use in premature infants and allows clinicians to implant the Amplatzer Piccolo Occluder using a single catheter rather than multiple catheters. The system’s shorter and softer design is intended to support more precise device positioning in very small patients.
“Abbott's new Amplatzer Piccolo Delivery System is a transformative step forward in how we treat PDA in premature infants,” said Evan Zahn, MD, professor of cardiology and pediatrics and director of the Guerin Family Congenital Heart Program, Cedars-Sinai Medical Center, Los Angeles, California. “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 itself is "smaller than a pea" and is currently the world’s first and only minimally invasive, transcatheter device approved to close a PDA in premature infants. During the procedure, the occluder is inserted through a small incision in the infant’s leg and guided through the blood vessels to the heart using the delivery system, where it is positioned to seal the opening. The occluder previously received FDA approval and CE Mark in 2019.
Abbott said the development of the new delivery system was guided by feedback from physicians around the world who routinely care for premature infants with PDA.
“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, in a statement. “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.”
In addition to the Amplatzer Piccolo platform, the company’s offerings include the Masters HP 15mm, and the HeartMate 3 heart pump, which is approved for pediatric patients.
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