HMN 2026: How Trial shows strong results for a first-of-its-kind stent for infants

A stent designed specifically for infants and young children with congenital heart disease has demonstrated strong safety and effectiveness in a pivotal multicenter clinical trial. Children’s Hospital Los Angeles led the national study and in 2022 performed the first-in-human implantation of the Minima stent, which can be expanded as a child grows—all the way to adult size.

The first-of-its-kind stent was approved by the Food and Drug Administration in 2024 for neonates, infants, and young children with coarctation of the aorta or branch pulmonary artery stenosis. Results from the trial were recently published in Circulation: Cardiovascular Interventions.

“The stent is doing what it was designed to do,” says Patrick Sullivan, MD, an interventional cardiologist in the Heart Institute at CHLA and first author of the study. “We found that it’s safe, has a very low complication rate, and effectively treats these obstructed blood vessels without the need for surgical intervention.”

Key findings

In the trial, 42 neonates, infants, and young children received the Minima stent. The device, which was developed by Renata Medical, was successfully placed in 97.6% of patients and consistently relieved vessel narrowing right away.

Safety outcomes were also reassuring. There were no serious device-related complications. As patients grew, some needed planned expansion of the stent—a key part of how the device is designed to work.

In addition, Dr. Sullivan presented longer-term follow-up data at the Pediatric Interventional Cardiology Symposium in October. Those data showed that, after about two years, roughly one-third of patients had undergone at least one stent expansion.

All expansions were performed safely and without the need for additional stents. As expected, children who were smaller at the time of implantation tended to require stent expansion sooner as they grew.

Although two stent embolizations occurred, these events were rare and managed successfully. Importantly, investigators did not observe vessel wall injury, stent fracture, or other unexpected safety concerns.

“As we’ve followed these patients over time, reinterventions have been driven by growth, not loss of stent performance,” says Dr. Sullivan. “That is what we want to see.”

A minimally invasive option

Although the study was not designed to change the standard of care for these conditions, the stent has opened up a new, minimally invasive option for babies who don’t respond to traditional interventions such as balloon angioplasty.

“For a long time, we simply haven’t had stents designed for our smallest patients,” says Darren Berman, MD, FPICS, FACC, FSCAI, national principal investigator of the study and director of congenital interventional catheterization at CHLA. “We now have the ability to safely deliver a stent for these babies, rather than adapting devices intended for adolescents or adults.”

Dr. Berman notes that having an expandable stent designed for infants and children may change how clinicians manage certain complex cases and has the potential to reduce the need for repeat open-heart surgery in select patients.

CHLA’s leadership of the trial reflects the Heart Institute’s focus on advancing care for infants and children with complex congenital heart disease.

“Bringing new technologies to patients requires an incredible amount of teamwork and expertise,” says Dr. Berman. “We’re excited to have an option that can support some of our smallest patients as they grow.”

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