The Minima Stent System is the only U.S. approved percutaneous device indicated for treating infant vascular stenosis.
Proven to be safe and effective for the treatment of coarctation of the aorta and pulmonary artery stenosis.
A Multicenter Pivotal Study of the Minima Stent System for Vascular Stenoses in Neonates, Infants, and Young Children
The objective of the clinical investigation is to assess device performance and the clinical safety and effectiveness of the Minima Stent in neonates, infants, and young children requiring intervention for common congenital vascular stenosis (i.e., coarctation of the aorta and/or pulmonary artery stenosis) who are indicated for treatment.
Prospective, multi-center, non-randomized treatment study with one arm.
Immediate Stenosis Relief
Freedom from surgical intervention
Maintenance of Stented Vessel Diameter
Freedom for procedure/device related SAEs
Number of
Patients treated
Median Age at
time of implant
Median Weight at
time of implant
Median Time to
first re-expansion
† At the time of data lock
Number of Patients Treated by Lesion Location
Supporting evidence from Renata and investigator sponsored studies
Results of the multicenter early feasibility study (EFS) of the Renata Minima stent as treatment for branch pulmonary artery stenosis and coarctation of aorta in infants.
Read Full Study
Preliminary testing and evaluation of the Renata Minima stent, an infant stent capable of achieving adult dimensions.
Read Full StudyRenata Medical supports Investigator Sponsored Research (ISR) studies that advance our
mission to improve the lives of children battling congenital heart defects.
† Through 6-month follow-up data lock
