Renata Medical has announced that the U.S. Food and Drug Administration (FDA) has approved its innovative Minima Growth Stent, designed specifically for neonates, infants, and young children. This unique stent is engineered to be re-expanded as the child grows, offering a significant advancement in treating congenital heart defects. This approval addresses a long-standing need expressed by pediatric cardiologists globally for over 30 years.
Renata Medical proudly announces the FDA approval of its groundbreaking Minima Stent, designed specifically for neonates, infants, and young children with congenital heart disease. “The approval of the Minima Stent marks a significant milestone for our company,” said Dustin Armer, Co-founder and CEO of Renata Medical. “We’ve achieved our goal of providing the first stent tailored for small, growing children, who are some of the most vulnerable and often overlooked patients.”
The Minima Stent addresses vessel narrowing, or stenosis, in the aorta and pulmonary arteries. These arteries are crucial for transporting oxygen-rich and oxygen-poor blood, respectively, and their narrowing can strain the heart, potentially leading to heart failure. Designed to be re-expanded as the child grows, the Minima Stent offers a minimally invasive solution for managing these conditions.
The stent is delivered through a small needle inserted into a vein or artery, and its unique design allows it to be crimped to under 2mm in diameter. This design facilitates easier access to the small veins and arteries in pediatric patients and allows the stent to expand effectively while keeping the vessel open. Most patients require only a one-day hospital stay, and some may go home the same day as the expansion procedure.
Dr. Evan Zahn, Director of the Congenital Heart Program at Cedars-Sinai Medical Center and Chief Medical Officer at Renata Medical, emphasized the impact of the stent: “The Minima Stent represents a monumental advancement for our field, offering a minimally invasive solution specifically designed for infants and small children.”
The FDA’s approval was based on data from the GROWTH Pivotal trial, which demonstrated that 97.6% of patients experienced effective stenosis relief, with 100% free from additional surgical intervention at six months. The trial also showed a favorable safety profile, with no major device-related adverse events reported.
Renata Medical’s Minima Stent System is now commercially available in the U.S., and the company plans to continue leveraging its Growth Technology for future innovations. “We developed the Minima Stent in collaboration with leading experts to provide a vital option for congenital heart disease patients,” said Eason Abbott, Co-founder and COO. “We hope this is just the beginning of many devices to enhance outcomes for our smallest patients.”
