Approximately 40,000 babies are born each year in the United States with a heart defect, according to the U.S. Centers for Disease Control and Prevention. Many of these infants have narrowing in either the aorta, which carries blood from the heart to the rest of the body, or the pulmonary artery, which transports blood from the heart to the lungs. While the first stent was approved by the FDA in 1994, it was designed for adults. Until now, the only solution for babies with narrowed blood vessels has been to resize adult stents to fit their small vessels, requiring multiple replacements as the child grows. However, a new device specifically designed for infants with narrowed blood vessels is now available.

Researchers at Cedars-Sinai (Los Angeles, CA, USA), in collaboration with Renata Medical (Newport Beach, CA, USA), have developed and tested the Minima Stent System, a stent designed to grow with a child. Featuring a unique cell design, the stent can expand as the child grows, eliminating the need for open-heart surgery. Instead, the expansion is performed during a two-hour catheterization procedure, with children typically able to go home the day after the procedure. The stent, made from a metal mesh, is designed to keep blood vessels open in newborns, infants, and children with narrowing in the aorta or pulmonary artery. Its ability to expand as the child grows is intended to reduce the need for additional surgeries as larger stents are needed over time.

The U.S. Food and Drug Administration has recently approved the Minima Stent System for use in newborns, infants, and children with narrowing in the aorta or pulmonary artery. Cedars-Sinai is one of the few hospitals in the U.S. where interventional cardiologists are trained to deploy the stent and offer specialized care to children who need it. Cedars-Sinai was also one of four medical centers that participated in an early feasibility study, which helped secure FDA approval for the stent. Results of the study, published in the journal Clinical Science, demonstrated that the stent was successfully implanted and effectively opened narrowed blood vessels.

“The stents we have had up to this point have had a fixed maximum diameter, meaning that baby is going to need to get it replaced, typically through open-heart surgery,” said Evan Zahn, MD, director of the Pediatric Congenital Heart Program at Guerin Children’s and in the Department of Cardiology in the Smidt Heart Institute, and chief medical officer of Renata Medical, who helped develop the new stent. “This approval represents a monumental shift in the way we care for babies with congenital heart disease. It is a joy to know how many patients and families will be positively impacted now that the stent is more widely available.”

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