Renata Medical - Physicians

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Implant now with confidence for the future

The Minima Pro stent comes pre-mounted and front loaded on an integrated delivery system, equivalent to a 4F sheath, and incorporates an updated stent design, delivery system enhancements, and a new 10 mm balloon option*.

In the years ahead, a simple off-the-shelf balloon may be used to re-expand the Minima Pro™ stent, accommodating the growth of the patient.

*Clinical data of re-expansions up to 10mm diameter with  on-going 5 year follow up.

A Multicenter Pivotal Study of the MinimaStent System for Vascular Stenoses in Neonates, Infants, and Young Children

US Pivotal Minima Pro™ Stent System GROWTH Trial^†

Due to the similarities in the Minima Stent and Delivery System and Minima Pro Stent and Delivery System designs, the results of the GROWTH study are applicable to the Minima Pro Stent and Delivery System.*

Objective

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.

Design

Prospective, multi-center, non-randomized treatment study with one arm.

Primary Efficacy Endpoints

Immediate Stenosis Relief
Freedom from surgical intervention
Maintenance of Stented Vessel Diameter

Primary Safety Endpoints

Freedom for procedure/device related SAEs

GROWTH Trial Midterm Follow-Up

Updated 8/30/2026

21/42

PATIENTS UNDERWENT
Re-Dialation

‍32 re-dilations total — 10 had a second, 1 a third. Median 3.4-year follow-up across all 42 implants.

50%

NO REPEAT RE-DILATION

Half the cohort needed no further  re-dilation over a median 3.4 years — despite young age and small size at implant.

1

STENT-RELATED AE

Across 32 re-dilations: one small pseudoaneurysm, no intervention.  Of 5 total AEs, two were vascular access.

RE-DILATION CHARACTERISTICS

RE-DILATION

CHARACTERISTICS

Median time to re-dilation: 419 d (1st), 776 d (2nd), 1341 d (3rd)
Lumen diameter stable between re-dilations at 92% (56-100%)
Younger age & lower weight at implant → earlier re-intervention; no single - vs biventricular difference

DISTAL NATIVE VESSEL GROWTH

DISTAL NATIVE

VESSEL GROWTH

Median vessel diameter distal to the stent - implant vs. most recent re-dilation.
Native vessel grew between reinterventions in both indications

Values in mm. Native vessel grew between reinterventions in both indications.

CASE IN POINT • SERIAL

RE-DILATION

CASE IN POINT • SERIAL RE-DILATION

A 6-month-old with hypoplastic left heart, 
re-dilated to match the growing vessel

A 6-month-old female with hypoplastic left heart syndrome, palliated through a bidirectional Glenn and complicated by left pulmonary artery (LPA) hypoplasia. The LPA was stented with the Minima Stent System on a 6 mm balloon, then re-dilated in 2mm increments at 12, 18, and 44 months — the most recent with an ultra-high-pressure balloon to match the native vessel. Distal LPA-hilum diameter grew from 4.2 mm at implant to 8.9 mm, alongside marked gains in stent caliber.

Additional Clinical Evidence

Supporting Evidence from Renata and Investigator Sponsored Studies

January 28, 2026

Late Aortic Obstruction Post Patent Ductus Arteriosus Closure Managed with Renata Minima Stent

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May 12, 2024

Results of the multicenter earlyfeasibility study (EFS) of the Renata Minima stent as treatment forbranch pulmonary artery stenosis and coarctation of aorta in infants.

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January 4, 2024

The Renata Minima Stent, a Low-Profile Stent for Infants Designed to Reach Adult Sizes, Completes Pivotal Trial Enrollment

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May 4, 2021

Preliminary testing and evaluation of the Renata Minima stent, an infant stent capable of achieving adult dimensions.

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The Renata Minima Stent system has the potential to really change how we treat kids over a lifetime.

Dr. Patrick Sullivan

Pediatric Cardiologist,
Children’s Hospital of Los Angeles
Heart Institute Assistant Professor of Pediatrics
University of Southern California,
Keck School of Medicine

Thank you for
your request.

Implant now with confidence for the future