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# Renata Expandable Growth Stent OK’d for Infants
- URL: https://www.fdaweb.com/renata-expandable-growth-stent-okd-for-infants/
- Published: 2024-08-29T12:00:00.000Z
- Updated: 2026-09-14T14:39:53.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5157684

FDA has approved a Renata Medical PMA for its Minima Growth Stent that’s intended for treating congenital heart disease in neonates, infants, and young children. The device is designed to be “re-expanded” over the course of the patients’ growth period.

The stent is indicated for treating vessel narrowing (stenosis) in the aorta or pulmonary arteries, Renata Medical says. “Like most interventional procedures, Minima is delivered through the vein or artery in the groin or neck with a small needle,” it says. “One of the biggest challenges faced by pediatric interventional cardiologists is gaining access to these very small veins and arteries, which can be smaller than a standard straw.” The stent is designed with long, thin struts that allow it to be crimped down to less than 2mm, it says, adding that its design also allows for expansion to larger sizes while maintaining enough force to keep the narrowed vessel open.

Approval is based on data from the GROWTH pivotal trial, which the company says showed that 97.6% of patients with the Minima Stent had effective stenosis relief, and 100% were free from additional surgical intervention at six months post-implantation. It says the study also demonstrated a favorable safety profile, with 100% of patients being free of major device-related adverse events through six months.