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FDA Approves Pea-sized Implant

Abbott has received FDA approval for its Amplatzer Piccolo Occluder, which the medtech giant describes as the world’s first implant designed for babies weighing as little as two pounds.

The device, smaller than a pea, is used in a minimally invasive procedure to treat patent ductus arteriosus, a life-threatening opening in the hearts of premature infants and newborns that requires urgent corrective treatment.

One of the most common congenital heart defects in premature babies, PDA is an opening between two blood vessels leading from the heart that fails to close during normal development. The open channel allows for the flow of oxygen-rich blood from the mother before birth. When the pathway fails to close, the increased blood flow to the lungs can make it difficult for premature babies to breathe normally.

PDAs account for up to 10% of all congenital heart disease, Abbott said, and that, of the 60,000 premature babies born in the U.S. each year with very low birth weights, nearly 20% will have a PDA significant enough to cause dangerous symptoms.

"This approval is a potentially life-saving advance for the very smallest premature infants that will help us treat these delicate babies who might otherwise not be able to survive," said Evan Zahn, director of the congenital heart program at Cedars-Sinai's Smidt Heart Institute and principal investigator for the study that led to approval.

The occluder is a self-expanding wire mesh device inserted through a small incision in the leg and guided through blood vessels to the heart, where it seals the opening. It is designed to be inserted through the aortic or pulmonary arteries and can be retrieved and redeployed for optimal placement.

The Piccolo device joins Abbott's family of Amplatzer Occluder therapies, including the already approved Duct Occluder II for treating PDA in larger pediatric patients.

"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," said Michael Dale, vice president for Abbott's structural heart business.

Last March, the FDA approved Abbott’s Masters HP 15mm device, the world’s smallest mechanical heart valve, designed for infants and children who need mitral or aortic valve replacement.

Initially developed by St. Jude Medical before it was acquired by Abbott, the rotatable device is a smaller version—about the size of a dime—of the valve first approved by the agency in 1995, featuring pyrolytic carbon leaflets and orifice rings.


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