Two infants with narrowed blood vessels received Renata Medical’s Minima Stent at the Children’s Heart Institute at Miller Children’s & Women’s Hospital in Long Beach, according to the hospital’s announcement. The report did not provide the infants’ diagnoses or individual outcomes.
What the device is designed to do
The Minima is intended for pulmonary artery stenosis or coarctation of the aorta in neonates, infants and children weighing at least 1.5 kilograms, or about 3.3 pounds. The hospital describes it as the first FDA-approved stent system specifically designed for those patients, while Children’s Hospital Los Angeles says the FDA approved it in 2024 for the same conditions. Unlike stents that may require replacement as a child grows, the Minima can be widened over time toward adult vessel size, according to the CHLA trial summary and the Miller announcement.
How implantation works
Doctors place the stent through a catheter inserted generally through a vein or artery in the leg, rather than opening the chest. Miller Children’s said that approach can help some infants with vascular stenosis avoid open-heart surgery. The hospital’s Saar Danon said in the announcement that the ability to treat serious narrowing earlier may reduce the need for later operations, but the device’s design still requires monitoring and possible expansion as a child grows.
What the clinical evidence shows
CHLA led a multicenter pivotal trial involving 42 neonates, infants and young children. The Minima was successfully placed in 97.6% of patients and immediately relieved the targeted narrowing, according to CHLA. The hospital reported no serious device-related complications overall, although two stents moved out of position and were managed successfully.
The same follow-up also shows why the device should not be described as a one-time solution. After about two years, roughly one-third of the trial participants had undergone at least one planned expansion. CHLA has said children may need two to four expansions over their lives. The trial summary describes the device as a minimally invasive option that may reduce repeat open-heart surgery in selected patients; it does not establish that every child will avoid additional procedures.
For the two Long Beach patients, the hospital has announced the procedures as an expansion of treatment options for infants but has not publicly supplied further patient-specific details in the material cited here. Danon said the technology could allow treatment earlier in life while limiting future surgical interventions, a conclusion that remains broader than the limited information released about these two cases.
